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The Center for Professional Advancement, 90 Minute Accredited Online Training
November 3, 2009 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This course is designed for professionals in the pharmaceutical, biopharmaceutical and biologics industries. It will be especially beneficial to:
• Clinical researchers
• CROs
• Regulatory professionals
• Biomedical researchers
Description
This 90-minute accredited online training explores the FDA's concerns about the make up, responsibilities, and independence of IRBs, and outlines FDA revision issues and future regulatory audit plans.
Module 1: IRB Problems
• Importance of IRBs
– Past abuses
– Growing complexity of clinical trials
• FDA questions about IRBs
– Expertise, resources, independence
• Ultimate IRB goal: patient protection
– In clinical trials: critical, complex
Module 2: IRB Solutions
• Proactive: Join, don't fight, the FDA
– Concerns are legitimate
– Current system leaves patient protection gap
• Consensus on need for independence; some agreement
on expertise
• Possible strategies include:
– Self Regulation
– FDA Cooperation
– Code of Conduct
• Stumbling Block: On Site
Module 3: The Future: Likely FDA Actions
• Issues:
– Expertise, Independence, Site Monitoring Capabilities
• Recommendations by key players
– IRB Managers
– CROs
– Clinical Study Owners
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Sandy Weinberg, Associate Professor of Health Care Management (Regulation) at Clayton State University, part of the Georgia State University System; retired regulatory professional from the drug, device and vaccine industries.
Dr. Weinberg is teaching and researching Regulation and Biodefense. He is a consultant to the FDA regulated industries and is a former consultant to the FDA and other international regulatory agencies including Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health.
He has been a leader in the field of system validation for more than twenty years, and a practitioner in regulatory submissions, auditing, international liaison and biodefense vaccine development. Dr. Weinberg is the author of numerous books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, Good Laboratory Practice Regulations, and The Handbook of Drug Regulatory Submissions. His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.
Dr. Weinberg is a member of the Board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands. Recently retired, Dr. Weinberg was Senior Director for Biodefense at GE Healthcare and Vice President of Tikvah Therapeutics; as well as an investor in and Board member of several international biomedical companies.
Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas. Recent projects include the auditing and certification of a chromatography control system; a business development and fund raising project for a biodefense vaccine company; an Orphan Drug submission; and the validation of a Laboratory Information Management System. Much of Dr. Weinberg’s practice is centered in the US, Western Europe and Israel.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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