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.
Monday, October 25, 2010
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.
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