ABOUT THIS WEBINAR

This webinar will:

Provide a general overview of the Bioresearch Monitoring (BIMO) program
Discuss Good Clinical Practice (GCP) inspectional processes, compliance evaluation and enforcement, including case examples
Summarize findings from a recent publication on follow-up inspectional activities after FDA notifies an inspected entity of serious-noncompliance
Include live Q&A session and a moderated panel discussion

TOPICS COVERED

Overview of CDER’s GCP BIMO Program
GCP inspections, including classification criteria, and case examples of serious non-compliance
Official Action Indicated (OAI) follow-up inspection procedures, findings, and trends

INTENDED AUDIENCE

Clinical investigators
Clinical research personnel (e.g., sub-investigators, study coordinators, regulatory specialists)
Sponsors, Contract Research Organizations (CROs)
Sponsor-Investigators
Institutional Review Board (IRBs)

FDA RESOURCES

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CDER BIMO GCP Compliance and Enforcement - 02/16/2022

Distribution channels: Healthcare & Pharmaceuticals Industry

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