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.
Wednesday, September 29, 2010
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.
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