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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

• 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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
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