In this web seminar, the content of the new 2010 draft guidance is reviewed in detail. Perhaps more importantly, the implications of how this guidance affects the essential documentation practices and activities between the sponsor, investigator, and the reviewing IRBs are examined. Also covered is how the guidance fits in with other recent releases by the agency that promote implementing a risk-based approach for all stakeholders in performing their regulatory requirements for FDA-regulated trials. For example, we will discuss the document’s suggested expansion of the current sponsor IRB information exchange practices, which clarify the sponsor’s role in regard to the IRB information submission that is vaguely spelled out in the regulations.
- Describe the history of what lead to the guidance release: Risk-based focus
- Describe the recommendations regarding the criteria, process, and frequency of continuing review
- Identify how the guidance recommendations differ from current practices
- Discuss the implications of the guidance on IRB, investigator, and sponsor activities
- Review case scenarios, including recent warning letters
- Investigators and Site Managers
- Research Coordinators
- IRB Professionals
- Clinical Research Associates
- Sponsor/CRO Managers
- Quality Assurance Personnel
Elizabeth Ronk Nelson, M.P.H.
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$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 778-0000-10-002-L01-P. Released: 5/10.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.