As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. The FDA’s recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventative action plans are developed to secure compliance. This web seminar will examine the trends in recent regulatory communication (warning, NIDPOE, NOOH letters and 483s) and open discussion for review of acceptable versus unacceptable responses.
- Review recent FDA findings for Clinical Investigators (sites), sponsors, and IRBs
- Determine areas of compliance concentration for CBER, CDER, and CDRH
- Discuss what factors may be helping drive the present approach and what it may mean for future compliance considerations
- Examine best practices for responding to a regulatory communication (e.g., a 483)
- Clinical Research Associates
- Project Managers
- Clinical Research Coordinators
- Clinical Principal Investigators
- IRB Administrators and Members
- Clinical Quality Assurance Auditors
- All other personnel responsible for ensuring compliance with GCP regulations
Elizabeth Ronk Nelson, M.P.H.
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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 +1 781.972.5400 or toll-free in the U.S. 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 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-12-024-L01-P. Released: 4/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.