Crackdown on Institutional Review Boards (IRBs)
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This course is available as a client site course. Please click here for more information.
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