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 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, Investigators, Study Coordinators, IRB Professionals, Institutional Officials involved in oversight of clinical research, and GCP-Focused Regulatory Affairs Professionals.
Elizabeth Ronk Nelson, M.P.H.
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2 hours; 9:30 - 11:30 a.m. Eastern
April 15, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471