Hector Colon from FDA’s Office of Regulatory Affairs provides an overview of bioresearch monitoring program (BIMO) inspection elements.
Marcia Helber from CDER’s Postmarketing Adverse Drug Experience (PADE) compliance team discusses elements of a PADE, how FDA uses inspection information, and best practices for PADE inspection.
Haley Seymour from CDER’s REMS compliance team discuses preparing for a REMS inspection.
Learn more at www.fda.gov/Dr...
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12 апр 2020
