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Pharmaceuticals, Medical Devices

BIMO General Inspection Assignment Process

About the Course

This is the second in a series of courses that provide an overview of FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used in conducting and reporting Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor, and in vivo Bioequivalence inspections. This compliance training course provides an overview of the general inspection assignment process, site selection, background materials used in a BIMO inspection, and regulatory consequences of the BIMO program.