The FDA announced in 2006 an initiative to modernize the regulation of clinical trials, including the BIMO inspections program. This includes conducting inspections and other assessments earlier in the development of a potential product to build quality into the clinical trial upfront rather than assessing it at trial completion. From this initiative, the FDA has generated new guidance and regulation that directly affect the performance of the sponsor monitor. The initiative is a dynamic process and this web seminar tracks the updates that directly affect monitoring. Examples of how to implement the agency requirements and recommendations into current practices and specific projects are also covered.
- Discuss the FDA BIMO initiative and the direct impact on sponsor monitoring
- Examine industry regulatory update impacting the role of the Clinical Research Associate
- Integrate strategies for determining appropriate role performance for earlier and more frequent sponsor monitoring inspections
- Apply tools and resources to implement the new required and recommended practices
- Clinical Research Associates (Pharma, Biologic, or Device)
- Contract Clinical Research Associates
- Sponsor Project Managers
- Clinical Research Associate Managers
Karen L. Gilbert, B.S., C.C.R.A.
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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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-005-L01-P. Released: 1/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.