is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 25th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.
Wednesday, December 15, 2010
Monday, December 13, 2010
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 19th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Friday, December 10, 2010
Medical Device Vigilance - Reporting Requirements in the EU
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, January 12th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The revised MEDDEV 2.12-1 Rev 6 guidance about medical device vigilance came into effect in December of 2009. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
The revised MEDDEV 2.12-1 Rev 6 guidance about medical device vigilance came into effect in December of 2009. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
Monday, December 6, 2010
Enhanced Monitoring Tools and Strategies to Optimize Productivity and Compliance
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Tuesday, January 11th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Thursday, December 2, 2010
Intended Use & Indications for Use – Does Anyone Know What They Mean? Does FDA?
is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, January 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Intended use. Indications for use. For years FDA has developed working definitions of these two terms, which vary from the definitions included in the regulations. Now FDA is questioning whether new definitions are needed. Previous industry use of the terms was based upon FDA's informal guidance, but if FDA doesn't know what they mean, does anyone?
In this audio conference, regulatory attorney Bob Klepinski discusses both the practical and the theoretical issues surrounding these two important terms and their use. The presentation looks at the statutory and regulatory definitions, and FDA's attempts to define them in guidance for industry. It also looks at what the future might hold, and how companies should proceed in the interim.
Intended use. Indications for use. For years FDA has developed working definitions of these two terms, which vary from the definitions included in the regulations. Now FDA is questioning whether new definitions are needed. Previous industry use of the terms was based upon FDA's informal guidance, but if FDA doesn't know what they mean, does anyone?
In this audio conference, regulatory attorney Bob Klepinski discusses both the practical and the theoretical issues surrounding these two important terms and their use. The presentation looks at the statutory and regulatory definitions, and FDA's attempts to define them in guidance for industry. It also looks at what the future might hold, and how companies should proceed in the interim.
Wednesday, November 17, 2010
HFE 101 – Essentials of Human Factors Engineering
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, December 16th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation is designed for those new to the integration of human factors research into product design, or those who want a basic overview of FDA requirements in this area. This presentation reviews several guidance documents issued by FDA regarding its human factors initiative, and the speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation is designed for those new to the integration of human factors research into product design, or those who want a basic overview of FDA requirements in this area. This presentation reviews several guidance documents issued by FDA regarding its human factors initiative, and the speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Tuesday, November 16, 2010
Risk-Based CAPA - New Guidelines and Expectations
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Tuesday, December 14th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Monday, November 15, 2010
Quality Monitoring and Reporting with Statistical Trending Analysis
is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, December 8th, 2010. For more details or to register, please visit our site at www.fxconferences.com
There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends. Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends. The intention of trending is two-fold, first it is to identify before the system goes out of control the potential for problems. Secondly, it helps to show improvement after a change to the system. Trending analysis can be applied to complaints, process data, nonconformances, CAPA and other quality system data.
Participants in this audio conference gain an increase in their awareness of how trending analysis can be used to report systematic data to management. Beyond graphical methods, the presentation covers statistical methods such as weighted moving averages and low occurrence trending.
There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends. Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends. The intention of trending is two-fold, first it is to identify before the system goes out of control the potential for problems. Secondly, it helps to show improvement after a change to the system. Trending analysis can be applied to complaints, process data, nonconformances, CAPA and other quality system data.
Participants in this audio conference gain an increase in their awareness of how trending analysis can be used to report systematic data to management. Beyond graphical methods, the presentation covers statistical methods such as weighted moving averages and low occurrence trending.
Monday, November 8, 2010
Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Thursday, December 9th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
Thursday, November 4, 2010
Complying with Employment Law When Interviewing & Hiring
is being presented by Marna Hayden, Founder and President, of Hayden Resources Inc. and airs on Thursday, December 2nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Hiring the right people is one of the most important jobs any human resources professional or manager does. From the entrance level recruiter to the seasoned professional in charge of executive hiring, this audio conference provides practical pointers on hiring best practices and pitfalls.
The presentation covers the interviewing and selection process from the perspective of compliance to applicable employment laws, and reviews each step. It covers what is allowed, what may be discriminatory, and what specific questions should not be asked in an employment interview. Our speaker also discusses how best to evaluate a candidate, how to measure what constitutes adverse impact in hiring, and how to legally conduct reference and background checks.
Hiring the right people is one of the most important jobs any human resources professional or manager does. From the entrance level recruiter to the seasoned professional in charge of executive hiring, this audio conference provides practical pointers on hiring best practices and pitfalls.
The presentation covers the interviewing and selection process from the perspective of compliance to applicable employment laws, and reviews each step. It covers what is allowed, what may be discriminatory, and what specific questions should not be asked in an employment interview. Our speaker also discusses how best to evaluate a candidate, how to measure what constitutes adverse impact in hiring, and how to legally conduct reference and background checks.
Tuesday, November 2, 2010
Using Standards for Attribute Sampling
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, December 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
This audio conference presentation helps attendees understand and implement acceptance sampling, explaining the basis for sampling plans, the binomial distribution, and showing how it helps us understand sampling plan performance using the operating characteristic (OC) curve. Participants gain a solid understanding of the risks involved in sampling by understanding the OC. Our speaker shows how the shape of curve describes risk, and identifies some of the most important points on the curve (AQL and RQL points).
The audio conference provides complete descriptions of three other important curves that help you understand a sampling plan: the average sample number (ASN), average outgoing quality (AOQ), and average total inspected (ATI).
The presentation provides a complete description of Z1.4, showing the process from receiving the lot to selecting the sample size to making the accept/reject decision. The speaker also examines c=0 plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. The presentation looks at some issues with converting from Z1.4 to c=0 plans, especially related to inventory levels and supplier evaluation.
This audio conference presentation helps attendees understand and implement acceptance sampling, explaining the basis for sampling plans, the binomial distribution, and showing how it helps us understand sampling plan performance using the operating characteristic (OC) curve. Participants gain a solid understanding of the risks involved in sampling by understanding the OC. Our speaker shows how the shape of curve describes risk, and identifies some of the most important points on the curve (AQL and RQL points).
The audio conference provides complete descriptions of three other important curves that help you understand a sampling plan: the average sample number (ASN), average outgoing quality (AOQ), and average total inspected (ATI).
The presentation provides a complete description of Z1.4, showing the process from receiving the lot to selecting the sample size to making the accept/reject decision. The speaker also examines c=0 plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. The presentation looks at some issues with converting from Z1.4 to c=0 plans, especially related to inventory levels and supplier evaluation.
Monday, October 25, 2010
Tips and Tricks for Effective eCTD Regulatory Strategy and eCTD Lifecycle Management
is being presented by Gina Ross, , Director, Quality Document Systems Management, with Beckloff Associates and airs on Tuesday, Novemeber 30th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
A sound regulatory strategy, combined with proactive lifecycle management of electronic submissions, can speed the regulatory review and approval process and reduce the regulatory burden, expand marketing applications to additional jurisdictions and drive successful regulatory approval outcomes.
To be truly successful at integrating regulatory strategy and eCTD lifecycle management, sponsors need to evaluate their existing document authoring and submission compilation activities and determine what, if any, modifications are necessary to accommodate the eCTD specifications. Document authors need to understand not only the CTD guidelines, but also have a working knowledge of the eCTD guidelines and application of the lifecycle operation attributes. Regulatory affairs and regulatory operations (i.e. publishers) need to have an in-depth knowledge of the CTD and eCTD guidelines, as well as the electronic requirements of multiple global regulatory agencies.
This audio conference is designed to help organizations and individuals understand the relationship between regulatory strategy and the eCTD lifecycle management, and to effectively develop systems, processes and procedures to support the chosen strategies and facilitate the future lifecycle management of applications.
A sound regulatory strategy, combined with proactive lifecycle management of electronic submissions, can speed the regulatory review and approval process and reduce the regulatory burden, expand marketing applications to additional jurisdictions and drive successful regulatory approval outcomes.
To be truly successful at integrating regulatory strategy and eCTD lifecycle management, sponsors need to evaluate their existing document authoring and submission compilation activities and determine what, if any, modifications are necessary to accommodate the eCTD specifications. Document authors need to understand not only the CTD guidelines, but also have a working knowledge of the eCTD guidelines and application of the lifecycle operation attributes. Regulatory affairs and regulatory operations (i.e. publishers) need to have an in-depth knowledge of the CTD and eCTD guidelines, as well as the electronic requirements of multiple global regulatory agencies.
This audio conference is designed to help organizations and individuals understand the relationship between regulatory strategy and the eCTD lifecycle management, and to effectively develop systems, processes and procedures to support the chosen strategies and facilitate the future lifecycle management of applications.
Tuesday, October 19, 2010
eLabeling for Medical Devices in the EU
is being presented by Joachim Wilke, Director, Regulatory Affairs & Policy, Europe
, with Medtronic and airs on Wednesday, November 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Get the very latest on European device labeling, from one of the architects of the legislation!
This audio conference discusses the background and status of the upcoming legislation on elabeling for medical devices in the European Union. Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for elabeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. Our speaker, who chairs Eucomed's Alternative Labeling Task Force, also reviews a number of topics still under discussion, and provides information about the political process and expected time scenario – as well as factors which could lead to potential delays. The presentation also raises some practical considerations on the implementation of elabeling for medical devices.
, with Medtronic and airs on Wednesday, November 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Get the very latest on European device labeling, from one of the architects of the legislation!
This audio conference discusses the background and status of the upcoming legislation on elabeling for medical devices in the European Union. Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for elabeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. Our speaker, who chairs Eucomed's Alternative Labeling Task Force, also reviews a number of topics still under discussion, and provides information about the political process and expected time scenario – as well as factors which could lead to potential delays. The presentation also raises some practical considerations on the implementation of elabeling for medical devices.
Friday, October 15, 2010
Academic Medical Centers and Clinical Research Productivity: How to Choose The Best Sites
is being presented by Anita S. Kablinger, Physician, Carilion Clinic
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?
This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?
This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.
Thursday, October 14, 2010
3 Steps to Successful Translation Management
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Tuesday, November 23rd, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Wednesday, October 13, 2010
Part 11 Compliance and CDER Tag-Along Inspections - Are You Ready?
is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, Novemeber 11th, 2010. For more details or to register, please visit our site at www.fxconferences.com
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
Tuesday, October 12, 2010
Automating Management Systems for Competitiveness & Sustainability
is being presented Jayne Pilot, President, of Pilot Performance Resources Management and airs on Thursday, November 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com
To be competitive on both a national and a global scale, organizations must adopt a forward-thinking approach in developing their management strategies. Many of today’s top managers come from the ranks of the baby boomers, and will reach their 60s and 70s in the next five years and retire from the workforce, taking with them a wealth of knowledge. Automation could help ease the blow by improving competence and competitive advantage for the global marketplace.
But what exactly is an automated management system? What does it encompass, and how can it help companies to be competitive and sustainable? In this audio conference, our speaker outlines how automation of management systems online can help companies manage both risks and sustainability.
To be competitive on both a national and a global scale, organizations must adopt a forward-thinking approach in developing their management strategies. Many of today’s top managers come from the ranks of the baby boomers, and will reach their 60s and 70s in the next five years and retire from the workforce, taking with them a wealth of knowledge. Automation could help ease the blow by improving competence and competitive advantage for the global marketplace.
But what exactly is an automated management system? What does it encompass, and how can it help companies to be competitive and sustainable? In this audio conference, our speaker outlines how automation of management systems online can help companies manage both risks and sustainability.
Thursday, October 7, 2010
Improving the Efficiency of Regulatory e-Submissions
is being presented by Donald Palmer, Associate Director, Regulatory Systems, with MedImmune and airs on Tuesday, November 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
As more companies work closely with partners, outsource partners, or CROs, the need to standardize processes and requirements for electronic submissions is becoming more pronounced. In addition, there is a need for these interactions to be efficient, from publishing processes and systems to document management, to the authoring process.
This audio conference presentation looks at the current types of processes and technology needed for electronic regulatory submissions, for companies both small and large. It also considers possible changes to these processes and technology, as a company grows and/or seeks to gain greater efficiencies. The speaker also looks at where tools might be developed and/or integrated for further efficiencies.
As more companies work closely with partners, outsource partners, or CROs, the need to standardize processes and requirements for electronic submissions is becoming more pronounced. In addition, there is a need for these interactions to be efficient, from publishing processes and systems to document management, to the authoring process.
This audio conference presentation looks at the current types of processes and technology needed for electronic regulatory submissions, for companies both small and large. It also considers possible changes to these processes and technology, as a company grows and/or seeks to gain greater efficiencies. The speaker also looks at where tools might be developed and/or integrated for further efficiencies.
Wednesday, October 6, 2010
505(b)(2) Submissions: Eligibility, Strategies & Preparation
is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, November 16th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.
In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.
There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.
In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.
Tuesday, October 5, 2010
Understanding QSR Acceptance Activities for Medical Devices
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, November 10th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA’s Quality System Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. This is one of the top five sections cited in FDA Warning Letters.
This audio conference explains the regulations and provides guidance on implementation. We analyze the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We also explain the guidance offered in FDA’s QSR Manual. This guidance helps manufacturers implement the regulations by clarifying the expectations and providing sample procedures and forms. This document is valuable, and even appears in an FDA Warning Letter as a recommendation to help a manufacturer come into full compliance.
The presentation includes an examination of some Warning Letters, reviews some mistakes that manufacturers have made, and looks at ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
The FDA’s Quality System Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. This is one of the top five sections cited in FDA Warning Letters.
This audio conference explains the regulations and provides guidance on implementation. We analyze the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We also explain the guidance offered in FDA’s QSR Manual. This guidance helps manufacturers implement the regulations by clarifying the expectations and providing sample procedures and forms. This document is valuable, and even appears in an FDA Warning Letter as a recommendation to help a manufacturer come into full compliance.
The presentation includes an examination of some Warning Letters, reviews some mistakes that manufacturers have made, and looks at ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
Monday, October 4, 2010
Effective Translation Process for Japan Regulatory Submissions
is being presented by Jason Heaton, Compliance Specialist, with ForeignExchange Translations, and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Many companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.
The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.
This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.
Many companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.
The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.
This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.
Friday, October 1, 2010
Putting an End to Workplace Bullying – Before It Becomes Law
is being presented by Jodie-Beth Galos, Esq., SPHR, Employment Law Attorney and airs on Tuesday, November 9th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Have you ever encountered a workplace bully – a manager, co-worker or someone you supervise? Most of us have -- and have the scars to prove it. Why do we allow this bad behavior to persist when we know it causes turnover, stress and dysfunctional teams, not to mention consuming hour upon hour of management time?
There are more than humanistic and management issues to consider. A number of states are entertaining legislation that would make workplace bullying unlawful – resulting in legal claims that could cost your organization huge amounts of money and untold amounts of bad press and public embarrassment. Plaintiffs’ lawyers rejoice when there’s a new reason to sue employers, forcing large settlements or winning enormous jury verdicts. In this timely audio conference, we consider the "No Jerks Rule" and how to bullet-proof your organization against workplace bullies and the associated fallout.
Have you ever encountered a workplace bully – a manager, co-worker or someone you supervise? Most of us have -- and have the scars to prove it. Why do we allow this bad behavior to persist when we know it causes turnover, stress and dysfunctional teams, not to mention consuming hour upon hour of management time?
There are more than humanistic and management issues to consider. A number of states are entertaining legislation that would make workplace bullying unlawful – resulting in legal claims that could cost your organization huge amounts of money and untold amounts of bad press and public embarrassment. Plaintiffs’ lawyers rejoice when there’s a new reason to sue employers, forcing large settlements or winning enormous jury verdicts. In this timely audio conference, we consider the "No Jerks Rule" and how to bullet-proof your organization against workplace bullies and the associated fallout.
Wednesday, September 29, 2010
Improving Data Manager and CRA Collaboration in an eClinical Environment
is being presented by Jonathan Andrus, Vice President, Data and Study Operations, eClinical Division, with BioClinica and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Clinical research professionals from the data management and clinical monitoring arenas don't always collaborate to the extent they should, and as a result miss out on opportunities to reduce “toe stepping” and data quality issues and to forge a better, more productive working relationship. This presentation focuses on steps that can be taken together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked.
Bringing together the data management and clinical monitoring groups early on in the study design and development and user acceptance process are some examples of how these groups can help ensure that varied and divergent ideas can be aligned for a better developed study database. However, beyond initial study design, the presentation addresses topics related to collaborative data review and cleaning during the conduct phase of the study. During study closeout, the successful lock of the database hinges on the close working relationship of the clinical field staff and the in-house data management staff. This presentation looks at how to make the study closeout process more effective, less time consuming, less redundant and more meaningful.
Clinical research professionals from the data management and clinical monitoring arenas don't always collaborate to the extent they should, and as a result miss out on opportunities to reduce “toe stepping” and data quality issues and to forge a better, more productive working relationship. This presentation focuses on steps that can be taken together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked.
Bringing together the data management and clinical monitoring groups early on in the study design and development and user acceptance process are some examples of how these groups can help ensure that varied and divergent ideas can be aligned for a better developed study database. However, beyond initial study design, the presentation addresses topics related to collaborative data review and cleaning during the conduct phase of the study. During study closeout, the successful lock of the database hinges on the close working relationship of the clinical field staff and the in-house data management staff. This presentation looks at how to make the study closeout process more effective, less time consuming, less redundant and more meaningful.
Tuesday, September 28, 2010
Readability Testing for Patient Information in Europe
is being presented by Simon Andriesen, CEO, of MediLingua BV and airs on Tuesday, November 2nd, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Readability testing of patient information leaflets has been the law in Europe since 2005. One on the language versions – English or any of the other EU languages – must be tested for readability. During a readability test a leaflet is discussed with 25 participants, who have to answer a range of questions using the information they find in the leaflet. This way most if not all errors or shortcomings will surface and can be corrected.
This audio conference presentation will provide an overview and best practices concerning readability testing. The speaker will discuss how to set up a test environment, how to recruit the right people for testing, and how to formulate strong, effective questions.
Readability testing of patient information leaflets has been the law in Europe since 2005. One on the language versions – English or any of the other EU languages – must be tested for readability. During a readability test a leaflet is discussed with 25 participants, who have to answer a range of questions using the information they find in the leaflet. This way most if not all errors or shortcomings will surface and can be corrected.
This audio conference presentation will provide an overview and best practices concerning readability testing. The speaker will discuss how to set up a test environment, how to recruit the right people for testing, and how to formulate strong, effective questions.
Monday, September 27, 2010
Hydrophilic Coating Options for Medical Devices
is being presented by Josh Simon, Senior Product Manager, Coating Technologies, with Biocoat, Inc. and airs on Thursday, November 4th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Hydrophilic materials attract water, and when used in medical device coatings, improve lubrication. This can be beneficial with products like catheters and wound dressings. However, not all coatings are created equal, nor are they appropriate in all cases. This audio conference provides an overview of hydrophilic coatings for medical devices, how they work, and when they should and should not be used. Our speaker provides attendees with valuable insight regarding the questions that should be asked when evaluating prospective vendors and coating options related to specific devices and applications.
Hydrophilic materials attract water, and when used in medical device coatings, improve lubrication. This can be beneficial with products like catheters and wound dressings. However, not all coatings are created equal, nor are they appropriate in all cases. This audio conference provides an overview of hydrophilic coatings for medical devices, how they work, and when they should and should not be used. Our speaker provides attendees with valuable insight regarding the questions that should be asked when evaluating prospective vendors and coating options related to specific devices and applications.
Wednesday, September 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Thursday, October 14th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Monday, September 20, 2010
Medical Device Vigilance - Reporting Requirements in the EU
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, October 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The revised MEDDEV 2.12-1 Rev 5 guidance about medical device vigilance came into effect on January 1, 2008. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
The revised MEDDEV 2.12-1 Rev 5 guidance about medical device vigilance came into effect on January 1, 2008. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
Friday, September 17, 2010
Dealing with Counterfeit and Substandard Pharmaceuticals
is being presented by Albert I. Wertheimer, Professor, Pharmacy Education and Research, with Temple University School of Pharmacy and airs on Thursday, October 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Until a few years ago, drug product counterfeiting was exclusively found in lesser developed countries, but with the sharp increase in drug prices in the USA and Western Europe, the practice has become more widespread.
This audio conference discusses how these drugs come into the country, and what can be done to identify and combat the practice. Our speaker examines the anti-counterfeiting strategies used in other industries where there is a lengthier history of this type of crime, industries such as finance, fine art, airplane parts and gemstones. Attendees gain an understanding of the nature and extent of the problem, and hear what is known and suspected regarding sources of counterfeits, and ways to prevent this criminal behavior. The speaker also discusses substandard products, a separate, but closely related problem around the world.
Until a few years ago, drug product counterfeiting was exclusively found in lesser developed countries, but with the sharp increase in drug prices in the USA and Western Europe, the practice has become more widespread.
This audio conference discusses how these drugs come into the country, and what can be done to identify and combat the practice. Our speaker examines the anti-counterfeiting strategies used in other industries where there is a lengthier history of this type of crime, industries such as finance, fine art, airplane parts and gemstones. Attendees gain an understanding of the nature and extent of the problem, and hear what is known and suspected regarding sources of counterfeits, and ways to prevent this criminal behavior. The speaker also discusses substandard products, a separate, but closely related problem around the world.
Thursday, September 16, 2010
Making Tough R&D Decisions When There Are Multiple Objectives
is being presented by Jack M. Kloeber Jr. & William K. Klimack, Partner & Senior Consultant, with Kromite LLC and airs on Tuesday, October 19th, 2010. For more information, or to register please visit our site at www.fxconferences.com
Making risky, complex decisions affecting the success of a company are part of every R&D leader's day, whether it be in the life sciences or any other industry. As R&D portfolios grow in size, they also grow in complexity, cost, and scientific or engineering difficulty. Executives facing tough decisions are often armed only with their own experience and intelligence and an army of advisors with conflicting objectives.
In this audio conference, our speakers propose a method of decision-making which helps the leader take key conflicting objectives into account consistently, while bringing clarity and transparency to the risk-cost-reward tradeoff discussion. The presentation draws upon a real-life examples from the new product development arena within the pharmaceutical industry. By focusing on achieving the core objectives of the company, leadership can identify the top projects and focus their scarce resources, thereby obtaining the largest value for their R&D efforts.
Making risky, complex decisions affecting the success of a company are part of every R&D leader's day, whether it be in the life sciences or any other industry. As R&D portfolios grow in size, they also grow in complexity, cost, and scientific or engineering difficulty. Executives facing tough decisions are often armed only with their own experience and intelligence and an army of advisors with conflicting objectives.
In this audio conference, our speakers propose a method of decision-making which helps the leader take key conflicting objectives into account consistently, while bringing clarity and transparency to the risk-cost-reward tradeoff discussion. The presentation draws upon a real-life examples from the new product development arena within the pharmaceutical industry. By focusing on achieving the core objectives of the company, leadership can identify the top projects and focus their scarce resources, thereby obtaining the largest value for their R&D efforts.
Tuesday, September 14, 2010
Successful Vendor Management in Clinical Trials
is being presented by Laurie Halloran, President and CEO, of Halloran Consulting Group, Inc. and airs on Wednesday, October 20th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Effective management of outsourced clinical programs is a critical skill in companies that use external vendors to provide the required services for conducting clinical trials. But why does a sponsor need to monitor a CRO, and what are the best methods to ensure adequate oversight? What best practices should companies follow to ensure quality and consistency of outsourced operational work? This audio conference discusses the essential knowledge and skills required to identify, qualify, select, set and manage expectations of vendors throughout clinical projects of all sizes.
Effective management of outsourced clinical programs is a critical skill in companies that use external vendors to provide the required services for conducting clinical trials. But why does a sponsor need to monitor a CRO, and what are the best methods to ensure adequate oversight? What best practices should companies follow to ensure quality and consistency of outsourced operational work? This audio conference discusses the essential knowledge and skills required to identify, qualify, select, set and manage expectations of vendors throughout clinical projects of all sizes.
Monday, September 13, 2010
Comparability of Recombinant Proteins Subject to Process Change: A Regulatory Perspective
is being presented by Dr. Gavin Edwards, Senior Consultant, with ERA Consulting (UK) Ltd and airs on Tuesday, October 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com
An inability to demonstrate product comparability following a process change is a common and serious error, however a well thought-out strategy for process change and the associated comparability exercise can ensure that regulatory pitfalls are avoided. In this audio conference, the speaker discusses the contents of ICH Q5E, using real-life examples to emphasize the main points. In addition, the presentation includes several case studies that illustrate the consequences resulting from a lack of comparability, for example, pure red cell aplasia associated with erythropoietin. Finally, the speaker also outlines procedures for seeking the advice of European regulators in relation to a process change.
An inability to demonstrate product comparability following a process change is a common and serious error, however a well thought-out strategy for process change and the associated comparability exercise can ensure that regulatory pitfalls are avoided. In this audio conference, the speaker discusses the contents of ICH Q5E, using real-life examples to emphasize the main points. In addition, the presentation includes several case studies that illustrate the consequences resulting from a lack of comparability, for example, pure red cell aplasia associated with erythropoietin. Finally, the speaker also outlines procedures for seeking the advice of European regulators in relation to a process change.
Friday, September 10, 2010
Regulatory and Practical Implications of e-Labeling for IVDs in Europe
is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, of Qarad and airs on Tuesday, October 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com
With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
Thursday, September 9, 2010
Electronic Drug Establishment Registrations and Drug Listings – One Year Later
is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Wednesday, October 6th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
New FDA requirements for electronic drug establishment registrations and drug listings took effect June 1, 2009. Many firms were initially surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. The challenges continue, as new validation rules are implemented, and as scrutiny of file content increases.
To make successful submissions, firms must not only have a technology solution in place (ESG account and SPL R4 file preparation and editing software), they must have a comprehensive understanding of file content requirements, of typical validation errors and how to avoid or overcome them. All of this may be accomplished through internal efforts or with help from a service provider.
This audio conference provides an overview of the current FDA requirements for drug registration and listing, and shares valuable insight gained over the past year.
New FDA requirements for electronic drug establishment registrations and drug listings took effect June 1, 2009. Many firms were initially surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. The challenges continue, as new validation rules are implemented, and as scrutiny of file content increases.
To make successful submissions, firms must not only have a technology solution in place (ESG account and SPL R4 file preparation and editing software), they must have a comprehensive understanding of file content requirements, of typical validation errors and how to avoid or overcome them. All of this may be accomplished through internal efforts or with help from a service provider.
This audio conference provides an overview of the current FDA requirements for drug registration and listing, and shares valuable insight gained over the past year.
Wednesday, September 8, 2010
Statistical Concepts of Medical Device Process Validation
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
Tuesday, September 7, 2010
Understanding the Connection Between Adverse Events and Product Liability Claims
is being presented by Caryn Silverman, Sedgwick, Detert, Partner, with Moran & Arnold LLP and airs on Tuesday, September 28th, 2010. For more details or to register, please visit our site at www.fxconferences.com
As life science companies strive to comply with adverse event reporting requirements, regulatory professionals should understand the product liability implications of doing so. Compliance with FDA regulations will not insulate your Company from product liability claims. In order to navigate the regulatory framework and challenges it creates with a focus on litigation mitigation and prevention, the regulatory practitioner should have a sound understanding of how adverse event reports are affirmatively used by plaintiffs’ attorneys.
This presentation showcases a series of on-going litigations and recent court decisions which highlight the use of adverse event reports, efforts to establish them as evidence of causation and the impact of foreign regulatory decisions. It also addresses the importance of developing specific business practices to thwart these efforts.
As life science companies strive to comply with adverse event reporting requirements, regulatory professionals should understand the product liability implications of doing so. Compliance with FDA regulations will not insulate your Company from product liability claims. In order to navigate the regulatory framework and challenges it creates with a focus on litigation mitigation and prevention, the regulatory practitioner should have a sound understanding of how adverse event reports are affirmatively used by plaintiffs’ attorneys.
This presentation showcases a series of on-going litigations and recent court decisions which highlight the use of adverse event reports, efforts to establish them as evidence of causation and the impact of foreign regulatory decisions. It also addresses the importance of developing specific business practices to thwart these efforts.
Wednesday, September 1, 2010
Feasibility: Laying The Foundation for a Successful Clinical Trial
is being presented by Kim Nelson, Director, Global Feasibility Strategy, with PPD and airs on Wednesday, October 6th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Clinical trial enrollment delays are common and can lead to increased study costs and extended time to market. A formal feasibility performed early in the development process can guide the project team through scenario planning that allows for more accurate planning.
By combining study-specific information collected through surveys or interviews with historical data from prior studies and other data sources, teams are able to make more informed enrollment projections that can aid in operational planning. These enrollment projections should then be combined with other relevant data such as insurance reimbursement, the regulatory environment, enthusiasm for the study therapy, regional differences or shifts in patterns of care and potential operational challenges to make country- and site-level recommendations. This presentation focuses on the steps of proper planning through a robust feasibility assessment to guide successful clinical trial completion.
Clinical trial enrollment delays are common and can lead to increased study costs and extended time to market. A formal feasibility performed early in the development process can guide the project team through scenario planning that allows for more accurate planning.
By combining study-specific information collected through surveys or interviews with historical data from prior studies and other data sources, teams are able to make more informed enrollment projections that can aid in operational planning. These enrollment projections should then be combined with other relevant data such as insurance reimbursement, the regulatory environment, enthusiasm for the study therapy, regional differences or shifts in patterns of care and potential operational challenges to make country- and site-level recommendations. This presentation focuses on the steps of proper planning through a robust feasibility assessment to guide successful clinical trial completion.
Tuesday, August 31, 2010
Establishing Win-Win Relationships With Internal Clients
is being presented by Herb Cohen, Senior Managing Partner, with Performance Connections International, Inc. and airs on Wednesday, September 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Successful scientists, engineers and IT professionals realize the importance of developing ongoing and productive “win-win” relationships with others outside their own department. Especially when resources are stretched, influencing and negotiating with coworkers in different areas of the company to gain their time and commitment to meet your needs is critical to the success of your business.
When your goal is to influence coworkers, you often face unique challenges and issues. While you and your coworkers all support the greater needs of the company, understanding each other’s individual and departmental issues is important in getting results. This isn’t always simple to do, and, in fact, can become even more complicated when you must make your case to a group, rather than to an individual.
This audio conference discusses how the genetic wiring of most technical professionals is different than other occupational groups. Speaker Herb Cohen explains how to resolve issues in a positive way that maintains the internal customer relationship, and shares top strategies that are mutually beneficial to everyone and that will benefit you and your company in both the short and long term.
Successful scientists, engineers and IT professionals realize the importance of developing ongoing and productive “win-win” relationships with others outside their own department. Especially when resources are stretched, influencing and negotiating with coworkers in different areas of the company to gain their time and commitment to meet your needs is critical to the success of your business.
When your goal is to influence coworkers, you often face unique challenges and issues. While you and your coworkers all support the greater needs of the company, understanding each other’s individual and departmental issues is important in getting results. This isn’t always simple to do, and, in fact, can become even more complicated when you must make your case to a group, rather than to an individual.
This audio conference discusses how the genetic wiring of most technical professionals is different than other occupational groups. Speaker Herb Cohen explains how to resolve issues in a positive way that maintains the internal customer relationship, and shares top strategies that are mutually beneficial to everyone and that will benefit you and your company in both the short and long term.
Friday, August 27, 2010
Comparative Effectiveness Research: Threat or Opportunity?
is being presented by Dr. Edward E. Berger, Principal and Founder, of Larchmont Strategic Advisors and airs on Wednesday, September 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.
This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.
Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.
This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.
Wednesday, August 25, 2010
Sustainability: The Business Case and Beyond
is being presented by Federico Fische, Renewable Energy Consultant and airs on Wednesday, November 17th, 2010. For more details or to register, please visit our site at www.fxconferences.com
We are constantly being bombarded by terms like green, sustainable, and social responsibility. Corporations, state and municipal officials and consumers are being urged to reduce their “carbon footprint” and to become more “green” and “sustainable.”
Both the public and private sector are engaged in parallel decision-making processes addressing the environment and the sustainability of the society as a whole. These decisions will affect the way corporations and government work, and the shape of the business environment. Changes in consumer behavior will affect how corporations and government will deliver their goods and services. The goal is to raise the level of debate on climate change and the environment, and promote an understanding of what government officials at the federal, state and municipal level are trying to say and do. This audio conference looks at the concepts behind the trendy buzzwords, and examines both the social and business case for 'going green'.
We are constantly being bombarded by terms like green, sustainable, and social responsibility. Corporations, state and municipal officials and consumers are being urged to reduce their “carbon footprint” and to become more “green” and “sustainable.”
Both the public and private sector are engaged in parallel decision-making processes addressing the environment and the sustainability of the society as a whole. These decisions will affect the way corporations and government work, and the shape of the business environment. Changes in consumer behavior will affect how corporations and government will deliver their goods and services. The goal is to raise the level of debate on climate change and the environment, and promote an understanding of what government officials at the federal, state and municipal level are trying to say and do. This audio conference looks at the concepts behind the trendy buzzwords, and examines both the social and business case for 'going green'.
Tuesday, August 24, 2010
Budgeting for Translations
is being presented by Jason Heaton, of ForeignExchange Translations and airs on Wednesday, September 29th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.
The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.
This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.
Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.
The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.
This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.
Monday, August 23, 2010
CGMP Guidance for Phase 1 Clinical Supplies
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
Friday, August 20, 2010
Human Factors Requirements and Usability Testing for Medical Devices
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, September 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Wednesday, August 18, 2010
The Virtual CRO: Future of Drug Development Partnerships?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Thursday, September 30th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.
But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.
The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.
But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.
Tuesday, August 17, 2010
Strategic Portfolio Management for Medical Devices
is being presented by Bill Poston, Managing Partner, Kalypso and airs on Wednesday, September 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
In today’s challenging market, an effective portfolio management process is essential to help medical device companies select those product ideas with the greatest commercial potential, and thereby maximize the return on their investments even when resources are limited. However, there is a big difference between portfolio management theory and how it is typically practiced in leading corporations. Product Portfolio Management (PPM) best practices and software should facilitate and support real-time portfolio analysis, but are they really being leveraged to their greatest benefit?
This audio conference presentation explores a practical, real-world approach to simple product portfolio management that will enable your company to define priorities and deliver on strategic objectives. The speaker provides valuable insight on six pragmatic PPM practices that add the most value with the least amount of effort.
In today’s challenging market, an effective portfolio management process is essential to help medical device companies select those product ideas with the greatest commercial potential, and thereby maximize the return on their investments even when resources are limited. However, there is a big difference between portfolio management theory and how it is typically practiced in leading corporations. Product Portfolio Management (PPM) best practices and software should facilitate and support real-time portfolio analysis, but are they really being leveraged to their greatest benefit?
This audio conference presentation explores a practical, real-world approach to simple product portfolio management that will enable your company to define priorities and deliver on strategic objectives. The speaker provides valuable insight on six pragmatic PPM practices that add the most value with the least amount of effort.
Monday, August 16, 2010
Renewable Energy: Industry Overview & Current Trends
is being presented by Federico Fische, Renewable Energy Consultant and airs on Wednesday, October 13th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Renewable energy is a mature sector and is constantly being tested for reliability as the alternative to fossil fuels. The government – both at federal and state level, politicians, entrepreneurs, academics and the media are bombarding the market with information, regulations, incentives, new ideas and technologies.
Most of the time, this information is about the promising future of renewable energy. However, this presentation focuses on the present and covers the basics: concepts and terminology, alternative technologies and their uses, and current trends and solutions. All US States have their own mandates on renewable energy and Congress is considering a federal bill too. In this environment, it is important that consumers, companies and other organizations understand what renewable energy is all about, to support their decision-making process.
Renewable energy is a mature sector and is constantly being tested for reliability as the alternative to fossil fuels. The government – both at federal and state level, politicians, entrepreneurs, academics and the media are bombarding the market with information, regulations, incentives, new ideas and technologies.
Most of the time, this information is about the promising future of renewable energy. However, this presentation focuses on the present and covers the basics: concepts and terminology, alternative technologies and their uses, and current trends and solutions. All US States have their own mandates on renewable energy and Congress is considering a federal bill too. In this environment, it is important that consumers, companies and other organizations understand what renewable energy is all about, to support their decision-making process.
Friday, August 13, 2010
Using Local Laboratory Data in Phase II and III Pivotal Studies
is being presented by Jaap H.M. Dijkman, CEO, of Medial NL and airs on Thursday, September 23rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.
Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.
Thursday, August 12, 2010
Optimizing Resource Allocation and Capacity Planning
is being presented by Vladimir Shnaydman, President, of ORBee Consulting and airs on Wednesday, September 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Under constant pressure to reduce the cost of drug development, many biopharmaceutical companies and CROs are looking for ways to improve their capacity planning and resource allocation. It is critical for clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for a portfolio of clinical trials. An optimal capacity planning solution includes proper resource utilization, allocation between ongoing and new trials, outsourcing strategy, hiring trend and budget allocation strategy for a variety of employee roles, and resource reallocation due to new or cancelled trials. It means identifying resource bottlenecks and optimal scheduling of new trials.
In this presentation, the speaker discusses a powerful decision-making methodology based on rigorous mathematical models for optimal capacity planning and resource allocation in clinical research, a technique which has been shown to reduce costs by up to 30% in some cases by uncovering better resource allocation solutions.
Under constant pressure to reduce the cost of drug development, many biopharmaceutical companies and CROs are looking for ways to improve their capacity planning and resource allocation. It is critical for clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for a portfolio of clinical trials. An optimal capacity planning solution includes proper resource utilization, allocation between ongoing and new trials, outsourcing strategy, hiring trend and budget allocation strategy for a variety of employee roles, and resource reallocation due to new or cancelled trials. It means identifying resource bottlenecks and optimal scheduling of new trials.
In this presentation, the speaker discusses a powerful decision-making methodology based on rigorous mathematical models for optimal capacity planning and resource allocation in clinical research, a technique which has been shown to reduce costs by up to 30% in some cases by uncovering better resource allocation solutions.
Wednesday, August 11, 2010
Conducting Laboratory Out-of-Specification Investigations
is being presented by Jerry Lanese, President, of The Lanese Group, Inc and airs on Tuesday, September 7th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Inadequate procedures for laboratory out-of-specification (OOS) investigations remains high on the list of FDA observations. Although the FDA's interest in how pharmaceutical firms handle OOS laboratory results began more than 15 years ago, and the Agency has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA investigator review and findings.
An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this audio conference we discuss the investigation that goes on within the laboratory. Although the focus is on the FDA guidance, the discussion includes suggestions for a process that will meet the FDA expectations.
Inadequate procedures for laboratory out-of-specification (OOS) investigations remains high on the list of FDA observations. Although the FDA's interest in how pharmaceutical firms handle OOS laboratory results began more than 15 years ago, and the Agency has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA investigator review and findings.
An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this audio conference we discuss the investigation that goes on within the laboratory. Although the focus is on the FDA guidance, the discussion includes suggestions for a process that will meet the FDA expectations.
Tuesday, August 10, 2010
Failure Modes & Effects Analysis (FMEA)
is being presented by Angelo Scangas, President, of Quality Support Group, Inc. and airs on Tuesday, August 31st. For more details or to register for this event, please visit our site at www.fxconferences.com
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Monday, August 9, 2010
Preventing Bacterial and Mold Spore Excursions
is being presented by Jim Polarine, Technical Service Specialist, with STERIS Corporation and airs on Thursday, August 26th. For more details or to register, please visit our site at www.fxconferences.com
The pharma and biotech industry has seen an increase in the number and species of bacterial endospores and mold spores found in facilities. This presentation focuses on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms, and limit other sources of spore contamination. The speaker discusses sporicidal products and their efficacy, and presents data which can be used to address bacterial spore issues, also reviewing current sporicide regulation in the US and Europe.
The presentation covers current issues in the industry and provides a better understanding of how to prevent outbreaks. Registrants hear about industry experiences, and troubleshooting methods for bacterial spore contamination issues. The presentation is designed to provide a better understanding of how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical to developing a successful contamination control program.
The pharma and biotech industry has seen an increase in the number and species of bacterial endospores and mold spores found in facilities. This presentation focuses on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms, and limit other sources of spore contamination. The speaker discusses sporicidal products and their efficacy, and presents data which can be used to address bacterial spore issues, also reviewing current sporicide regulation in the US and Europe.
The presentation covers current issues in the industry and provides a better understanding of how to prevent outbreaks. Registrants hear about industry experiences, and troubleshooting methods for bacterial spore contamination issues. The presentation is designed to provide a better understanding of how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical to developing a successful contamination control program.
Thursday, July 29, 2010
Vigilance Planning for Device Trials Under the Revised MDD
is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Wednesday, September 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the European market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS).
In the EU the medical devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.
This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.
Manufacturers placing medical devices on the European market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS).
In the EU the medical devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.
This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.
Doing Business in Japan: Lessons from a Road Warrior
is being presented by Keith B. Russell, President, of Global Pharmaceutical Services Inc. and airs on Wednesday, September 8th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Do you know how to avoid being perceived as an 'ugly foreigner' when working in Japan? Does the idea of going to Japan on business create anxiety or sleepless nights? Do you worry about committing a faux pas – perhaps without even knowing – that could cast you and your company in an unflattering light? If so, this presentation is for you.
This audio conference discusses in detail everything you need to know related to the social, cultural and business issues you might encounter while working in Japan. Attendees benefit from the perspective of a road warrior who has traveled to Japan dozens of times over the past 23 years, and has spent up to 100 days a year in-country while working for a major international pharmaceutical company and as an independent entrepreneur.
Do you know how to avoid being perceived as an 'ugly foreigner' when working in Japan? Does the idea of going to Japan on business create anxiety or sleepless nights? Do you worry about committing a faux pas – perhaps without even knowing – that could cast you and your company in an unflattering light? If so, this presentation is for you.
This audio conference discusses in detail everything you need to know related to the social, cultural and business issues you might encounter while working in Japan. Attendees benefit from the perspective of a road warrior who has traveled to Japan dozens of times over the past 23 years, and has spent up to 100 days a year in-country while working for a major international pharmaceutical company and as an independent entrepreneur.
Thursday, July 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Tuesday, September 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Wednesday, July 21, 2010
Creating Usable, Engaging Websites
is being presented by Daniel Szuc, Principal Usability Consultant, with Apogee Usability Asia Ltd and airs on Tuesday, August 31st, 2010. For more details or to register, please visit our site at www.fxconferences.com
Have you ever thought about which websites you love to visit and why? Why are some sites so hard to use?
Usability isn’t a "nice-to-have" in web design — it is essential. If people find it hard to do what they need to on the your website, then research shows they just won’t use it. According to Arthur Andersen, "More than 83% of Internet users are likely to leave a website if they feel they have to make too many clicks to find what they're looking for."
Designing and building a corporate website is an expensive and time-consuming undertaking, and too often, the end product falls short of what visitors want. This presentation looks at how to incorporate usability thinking into website design, discussing common approaches to get customers involved to find out what they need, and how to evaluate and test your site for usability.
Have you ever thought about which websites you love to visit and why? Why are some sites so hard to use?
Usability isn’t a "nice-to-have" in web design — it is essential. If people find it hard to do what they need to on the your website, then research shows they just won’t use it. According to Arthur Andersen, "More than 83% of Internet users are likely to leave a website if they feel they have to make too many clicks to find what they're looking for."
Designing and building a corporate website is an expensive and time-consuming undertaking, and too often, the end product falls short of what visitors want. This presentation looks at how to incorporate usability thinking into website design, discussing common approaches to get customers involved to find out what they need, and how to evaluate and test your site for usability.
Tuesday, July 20, 2010
Failure Modes & Effects Analysis (FMEA)
is being presented by Angelo Scangas, President of Quality Support Group, Inc. and airs on Tuesday, August 31st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Friday, July 16, 2010
Human Factors Design, Testing & Risk Analysis
is being presented by William R. Mandel, Directory of Technology, with Oasis Medical Solutions and airs on Wednesday, August 25th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.
This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.
Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.
This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.
Thursday, July 15, 2010
Audio, Video & Subtitles: Localizing Multimedia Content
is being presented by Xavier Marchand, COO, of JBI Studios and airs on Wednesday, August 4th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Multimedia files using audio and video (A/V) have become an important part of training material and corporate communications for companies wanting to effectively address a global audience. However, this enriched content presents new challenges during the localization process: the multimedia component adds dramatically to the impact of communications, but can also prove costly if not handled properly.
This audio conference presents an overview of A/V localization, including a review of the various options for localizing A/V content, and the associated cost implications. Our speaker also discusses content development with an eye to streamlining translation, and provides strategies for organizing your assets to reduce translation and localization costs as well as turnaround time. Attendees also learn the common pitfalls to avoid during the multimedia localization process.
Multimedia files using audio and video (A/V) have become an important part of training material and corporate communications for companies wanting to effectively address a global audience. However, this enriched content presents new challenges during the localization process: the multimedia component adds dramatically to the impact of communications, but can also prove costly if not handled properly.
This audio conference presents an overview of A/V localization, including a review of the various options for localizing A/V content, and the associated cost implications. Our speaker also discusses content development with an eye to streamlining translation, and provides strategies for organizing your assets to reduce translation and localization costs as well as turnaround time. Attendees also learn the common pitfalls to avoid during the multimedia localization process.
Wednesday, July 14, 2010
QA Oversight of Contractors
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc and airs on Tuesday, August 24th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Tuesday, July 13, 2010
Process and SOP Development for Medical Device Companies
is being presented by Phil Guarino, Managing Partner, with Quality Solutions Now (QSN)and airs on Wednesday, August 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com
In order to thrive in today's economy, companies have had to "lean out" their organizations. With this push for a lean environment comes the responsibility to do things right the first time, and when issues arise and must be adressed, this must be done in a very efficient and compliant manner. This means re-engineering processes the right way.
This audio conference presentation focuses on how to create compliant yet efficient processes using 'lean compliance' techniques, which includes mapping process, determining inefficiencies and compliance gaps, with the end result being processes that are unambiguous and easy to follow. The speaker also discusses effective use of resources, employee involvement, abstract thinking, and effective change management, with the understanding that SOPs do not drive processes, processes drive SOPs.
In order to thrive in today's economy, companies have had to "lean out" their organizations. With this push for a lean environment comes the responsibility to do things right the first time, and when issues arise and must be adressed, this must be done in a very efficient and compliant manner. This means re-engineering processes the right way.
This audio conference presentation focuses on how to create compliant yet efficient processes using 'lean compliance' techniques, which includes mapping process, determining inefficiencies and compliance gaps, with the end result being processes that are unambiguous and easy to follow. The speaker also discusses effective use of resources, employee involvement, abstract thinking, and effective change management, with the understanding that SOPs do not drive processes, processes drive SOPs.
Monday, July 12, 2010
Selecting a Phase I Clinical Trial Site
is being presented by Lorraine S. DeCesare, President, with LS Drug Development, Inc. and airs on Tuesday, August 17th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
Friday, July 9, 2010
How to Measure Translation Quality
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Thursday, August 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The quality of translation lies in the eye of the beholder, making a "good" or "bad" judgement highly subjective. Miscommunication and stylistic preferences often mark these discussions and a surprising number of organizations and translation vendors have no quality system in place at all.
When there is no single, accepted definition of translation quality, how can organizations measure it? This audio conference will help you better understand the proven methodologies for measuring translation quality and sort through the myriad options available to find a solution that is right for you.
The quality of translation lies in the eye of the beholder, making a "good" or "bad" judgement highly subjective. Miscommunication and stylistic preferences often mark these discussions and a surprising number of organizations and translation vendors have no quality system in place at all.
When there is no single, accepted definition of translation quality, how can organizations measure it? This audio conference will help you better understand the proven methodologies for measuring translation quality and sort through the myriad options available to find a solution that is right for you.
Thursday, July 8, 2010
Stopping Workplace Absenteeism and FMLA Abuse
is being presented by Jodie-Beth Galos, Esq., SPHR, Employment Law Attorney and airs on Wednesday, August 11th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The old saying goes that 90% of life is showing up. Unfortunately, some employees routinely don't. These no-show employees cause resentment for the rest of the crew, and besides creating morale issues, absenteeism racks up millions of dollars each year in lost productivity. What innovative, legally-sound techniques can you use to confront chronic absenteeism, eliminate abuse and save money? This audio conference addresses how to avoid legal landmines -- federal and state laws critical to absenteeism issues. The focus is on confronting problem employees and nipping excuses in the bud (including FMLA intermittent leave abuses). The presentation also looks at creating effective policies to reduce abuse in order to combat negative morale before it poisons your organization. This practical, fast-paced program provides the very latest information on creative techniques to reduce employee absenteeism, foster employee accountability and improve your organization’s bottom line.
The old saying goes that 90% of life is showing up. Unfortunately, some employees routinely don't. These no-show employees cause resentment for the rest of the crew, and besides creating morale issues, absenteeism racks up millions of dollars each year in lost productivity. What innovative, legally-sound techniques can you use to confront chronic absenteeism, eliminate abuse and save money? This audio conference addresses how to avoid legal landmines -- federal and state laws critical to absenteeism issues. The focus is on confronting problem employees and nipping excuses in the bud (including FMLA intermittent leave abuses). The presentation also looks at creating effective policies to reduce abuse in order to combat negative morale before it poisons your organization. This practical, fast-paced program provides the very latest information on creative techniques to reduce employee absenteeism, foster employee accountability and improve your organization’s bottom line.
Tuesday, July 6, 2010
Strategic Immunogenicity Planning for Successful Biosimilar Development
is being presented by Ana T. Menendez, Senior Director, Biotechnology, with Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
Monday, July 5, 2010
A Practical Approach to Medical Device Risk Management
is being presented by Harvey Rudolph, Ph.D., HRRM, LLC, Risk Management Consultant and airs on Tuesday, August 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.
Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.
Wednesday, June 30, 2010
SAFE-BioPharma – The Final Step to Fully Electronic Processes
is being presented by Kay Bross, Program Director, Member and Vendor Relations, with SAFE-BioPharma Association and airs on Wednesday, July 28th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Many large pharmaceutical companies are transitioning to the SAFE-BioPharma digital identity and digital signature standard. The standard was developed by a consortium of biopharmaceutical and related companies with participation from the US FDA and the European Medicines Agency, and is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.
These sponsors are now asking CROs to obtain the necessary SAFE-BioPharma credentials to complete a fully electronic communication/transaction sharing circle. The payoff is faster exchanges and more readily accessible records, with accelerated turnaround for trial contract execution. Also, R&D eLab Notebook entries are secured into the future, and can be used as court evidence.
But how exactly do these digital identities and signatures differ from other electronic signatures, and what are the legal implications of using one over the other? In this audio conference, attendees get all the answers from Kay Bross of SAFE-BioPharma Association, the non-profit group that created and manages the SAFE-BioPharma® digital identity and digital signature standard.
Many large pharmaceutical companies are transitioning to the SAFE-BioPharma digital identity and digital signature standard. The standard was developed by a consortium of biopharmaceutical and related companies with participation from the US FDA and the European Medicines Agency, and is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.
These sponsors are now asking CROs to obtain the necessary SAFE-BioPharma credentials to complete a fully electronic communication/transaction sharing circle. The payoff is faster exchanges and more readily accessible records, with accelerated turnaround for trial contract execution. Also, R&D eLab Notebook entries are secured into the future, and can be used as court evidence.
But how exactly do these digital identities and signatures differ from other electronic signatures, and what are the legal implications of using one over the other? In this audio conference, attendees get all the answers from Kay Bross of SAFE-BioPharma Association, the non-profit group that created and manages the SAFE-BioPharma® digital identity and digital signature standard.
Monday, June 28, 2010
Strategic Immunogenicity Planning for Successful Biosimilar Development
is being presented by Ana T. Menendez, Senior Director, Biotechnology, Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
Thursday, June 24, 2010
The Future of Clinical Trial Site and Patient Recruitment Is Here
is being presented by Kent Tholke, Senior Vice President, Scientific and Medical Affairs, with PRA International and airs on Thursday, July 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
Monday, June 21, 2010
The FDA’s New Emphasis on Supplier Controls – What Device Manufacturers Need to Know
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Thursday, July 29th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.
This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.
The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.
This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.
Thursday, June 17, 2010
Logistical Considerations for Clinical Trials in India
is being presented by Anthony Leone & Stevie Hills, International Customer Service Manager & International Customer Service Supervisor, with World Courier, Inc. and airs on Tuesday, July 27th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
India is one of the primary emerging markets for the pharmaceutical and biotechnology industries. Clinical trial expenditure in India for 2010 is expected to reach one billion dollars. This projection greatly exceeds 2009 spend. While India offers many compelling reasons to attract focus in the emerging market arena it also presents logistical challenges.
This presentation focuses on how you can ensure regulatory compliance and supply chain integrity at any stage of the clinical study pipeline when conducting studies in India. Our speakers reveal what advance planning and effective partnerships with logistical providers can mean to the success of your projects. The presentation draws on real-life anecdotes to provide transportation advice and reinforce the necessity of doing your homework in order to successfully conduct clinical studies in India.
India is one of the primary emerging markets for the pharmaceutical and biotechnology industries. Clinical trial expenditure in India for 2010 is expected to reach one billion dollars. This projection greatly exceeds 2009 spend. While India offers many compelling reasons to attract focus in the emerging market arena it also presents logistical challenges.
This presentation focuses on how you can ensure regulatory compliance and supply chain integrity at any stage of the clinical study pipeline when conducting studies in India. Our speakers reveal what advance planning and effective partnerships with logistical providers can mean to the success of your projects. The presentation draws on real-life anecdotes to provide transportation advice and reinforce the necessity of doing your homework in order to successfully conduct clinical studies in India.
Wednesday, June 16, 2010
Cloud Computing for the FDA-Regulated Company
is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, July 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?
This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.
Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?
This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.
Tuesday, June 15, 2010
Using Practical Statistics to Interpret Stability Results
is being presented by Steven Walfish, President, of Statistical Outsourcing Services and airs on Wednesday, July 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
Friday, June 11, 2010
Managing Your Online Reputation
is being presented by Marcela Jenney, Marketing and Branding Strategist, with Latitudes and airs on Thursday, July 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Google has evolved from a brand name into a verb. Google provides its users with the most relevant and useful information, including facts about you, your expertise, your business, and personal life. When potential employers, clients, and leads are interested in you or your business, they use Google to check you out. In a 2009 study on online reputation commissioned by Microsoft, which includes data not just from the U.S. but also from the U.K., Germany, and France, 79% of U.S. hiring managers and job recruiters surveyed said they reviewed online information about job applicants. Most of those surveyed said that what they found online influenced their selection criteria.
As a professional, you are being “watched” online. Therefore, you must protect that online presence that is influencing the decision-making process of your stakeholders. In this presentation you will learn tips, techniques and methods you can use to manage your online reputation, like diagnosing your online presence, monitoring your name, and utilizing tools for identity management.
Google has evolved from a brand name into a verb. Google provides its users with the most relevant and useful information, including facts about you, your expertise, your business, and personal life. When potential employers, clients, and leads are interested in you or your business, they use Google to check you out. In a 2009 study on online reputation commissioned by Microsoft, which includes data not just from the U.S. but also from the U.K., Germany, and France, 79% of U.S. hiring managers and job recruiters surveyed said they reviewed online information about job applicants. Most of those surveyed said that what they found online influenced their selection criteria.
As a professional, you are being “watched” online. Therefore, you must protect that online presence that is influencing the decision-making process of your stakeholders. In this presentation you will learn tips, techniques and methods you can use to manage your online reputation, like diagnosing your online presence, monitoring your name, and utilizing tools for identity management.
Wednesday, June 9, 2010
Localization Tools for eLearning: Articulate, Flash and Captivate
is being presented by Xavier Marchand, COO, of JBI Studios and airs on Wednesday, July 7th, 2010. For more details or to register please visit our site at www.fxconferences.com
Corporate training departments can choose between a variety of tools to develop internal elearning courses, each with their pros and cons in terms of cost, versatility and learning curve. For those training a global workforce, the "localization-friendliness" of the tool can have have serious cost implications and become an important factor in the selection process. Separately, once the tool is chosen, being able to make full use of its features and capabilities can help smooth and speed up the localization process.
In this presentation our speaker, Xavier Marchand of JBI Studios, discusses three of the most popular elearning tools – Articulate, Captivate, and Flash – examining the relative strengths and weaknesses of each from a localization perspective.
Corporate training departments can choose between a variety of tools to develop internal elearning courses, each with their pros and cons in terms of cost, versatility and learning curve. For those training a global workforce, the "localization-friendliness" of the tool can have have serious cost implications and become an important factor in the selection process. Separately, once the tool is chosen, being able to make full use of its features and capabilities can help smooth and speed up the localization process.
In this presentation our speaker, Xavier Marchand of JBI Studios, discusses three of the most popular elearning tools – Articulate, Captivate, and Flash – examining the relative strengths and weaknesses of each from a localization perspective.
Tuesday, June 8, 2010
EU Regulatory and CMC/Quality Requirements for Advanced Therapy Medicinal Products
is being presented by Dr. Elliot Lawrence, Associate Director of Regulatory Affairs , with ERA Consulting (UK) Ltd. and airs on Tuesday, July 13th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.
This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.
Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.
This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.
Monday, June 7, 2010
Beyond Using SharePoint to Manage Regulatory Documents
is being presented by John Postle & Kent Fernald, Vice President, Life Sciences & Development Manager / CTO, with Court Square Group and airs on Thursday, July 8th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.
Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.
Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.
Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.
Thursday, June 3, 2010
Introduction to Software Localization
is being presented by Sandra La Brasca, Solutions Development Director, with ForeignExchange Translations and airs on Tuesday, July 6th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Forethought and planning is beneficial with any translation or localization project. With software localization, it becomes paramount. This presentation focuses on the importance of proper preparation before launching any software localization project. The speaker provides concrete examples of the issues that can arise in the absence of adequate planning – issues related to terminology, tools to be used and technical considerations such as proper software internationalization. Additionally, the presentation outlines the steps involved in localization from translation through final testing, and discusses the ROI of proper preparation, showing the costs incurred for internationalization versus fixing internationalization bugs later in the development process.
Forethought and planning is beneficial with any translation or localization project. With software localization, it becomes paramount. This presentation focuses on the importance of proper preparation before launching any software localization project. The speaker provides concrete examples of the issues that can arise in the absence of adequate planning – issues related to terminology, tools to be used and technical considerations such as proper software internationalization. Additionally, the presentation outlines the steps involved in localization from translation through final testing, and discusses the ROI of proper preparation, showing the costs incurred for internationalization versus fixing internationalization bugs later in the development process.
Monday, May 31, 2010
The New HIPAA and its Impact on Drug and Device Manufacturers
is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, July 1st, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Manufacturers of medical devices and drugs had enough exemptions in the HIPAA privacy regulation that they could obtain most needed information in spite of the stringent controls on privacy rights. Occasionally such manufacturers needed to work under a Business Associate Agreement (BAA). However, the new statutory changes, including the privacy provisions of the HITECH Act, greatly increase the risk to manufacturers who work under BAAs. They are now directly liable under the HIPAA security regulations.
In this audio conference, FDA compliance attorney Bob Klepinski discusses the implications of this latest round of changes, how drug and device companies are expected to conduct themselves within this new HIPAA world, and the perils of failing to do so.
Manufacturers of medical devices and drugs had enough exemptions in the HIPAA privacy regulation that they could obtain most needed information in spite of the stringent controls on privacy rights. Occasionally such manufacturers needed to work under a Business Associate Agreement (BAA). However, the new statutory changes, including the privacy provisions of the HITECH Act, greatly increase the risk to manufacturers who work under BAAs. They are now directly liable under the HIPAA security regulations.
In this audio conference, FDA compliance attorney Bob Klepinski discusses the implications of this latest round of changes, how drug and device companies are expected to conduct themselves within this new HIPAA world, and the perils of failing to do so.
Friday, May 28, 2010
A Common Sense Approach to FDA and ISO Compliance
is being presented by Susan Soderholm, Quality Manager & Certified Quality Auditor, Amcor Rigid Plastics and airs on Tuesday, June 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
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