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Webcast | Virtual

Event Title
CDER BIMO GCP Compliance and Enforcement
February 16, 2022


Date:
February 16, 2022
Time:
1:00 PM - 3:30 PM ET

Agenda

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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

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.


 
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