Webcast | Virtual
Event Title
CDER BIMO GCP Compliance and Enforcement
February 16, 2022
Event Title
CDER BIMO GCP Compliance and Enforcement
- Date:
- February 16, 2022
- Time:
- 1:00 PM - 3:30 PM ET
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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
- U.S. Food and Drug Administration. Bioresearch Monitoring Program (BIMO)
- Jung M, Swann RM, Anantha MS, Jamali F. An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations. Ther Innov Regul Sci. 2021 Sep;55(5):907-917. doi: 10.1007/s43441-021-00267-y. Epub 2021 Jun 8. PMID: 34101151; PMCID: PMC8332576.
- U.S. Food and Drug Administration, Investigations Operations Manual 2021
- U.S. Food and Drug Administration Bioresearch Monitoring Program (BIMO) Compliance Programs
- U.S. Food and Drug Administration, Regulatory Procedures Manual Chapter 4 Advisory Actions
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