Inspection Readiness: Understanding BIMO Inspection Req. for Sponsors, CROs, Monitors, Investigators скачать в хорошем качестве

Inspection Readiness: Understanding BIMO Inspection Req. for Sponsors, CROs, Monitors, Investigators

The primary reason the FDA performs inspections is to support its mission to protect the public by ensuring the safety and efficacy of drugs, biologics, and medical devices. In 2006, the FDA announced an initiative to modernize the regulation of clinical trials, including the Compliance Program Guidance Manual (CPGM) Bioresearch Monitoring Program (BIMO). The purpose of the FDA compliance program is to provide instructions to the FDA field investigator and the FDA center personnel in the conduct of FDA inspections. This web seminar will review both the FDA CPGM BIMO for sponsors, CROs, and monitors and the FDA CPGM BIMO for Clinical Investigators and Sponsor-Investigators.