As the number of clinical research trials conducted outside of the United States increases, the FDA has come under new scrutiny for its ability to monitor and inspect foreign clinical trials. This course will examine the changing landscape of clinical research and how the FDA is adapting its processes to address these challenges. This course will also provide models for site selection, site oversight, and preparing foreign clinical research sites for regulatory inspections. Participants will gain a greater understanding of current FDA inspection trends of foreign clinical research sites.
- Explore the changing landscape of foreign clinical research
- Examine current FDA inspection metrics and challenges
- Review models for selection and oversight of foreign clinical research sites
This course is recommended for experienced:
- Clinical Quality Assurance Professionals
- Clinical Research Associates
- Project Managers
- Study Coordinators
- IRB Professionals
- Institutional Officials involved in oversight of clinical research
- GCP-Focused Regulatory Affairs Professionals
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 1-800-856-2556 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#: 0778-0000-11-029-L01-P. Released: 4/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471