SBIA | CDER BIMO GCP Compliance and Enforcement Webinar

Tomorrow!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS CDER BIMO GCP Compliance and Enforcement TOMORROROW! February 16, 2022 1:00 – 3:30 PM ET Register Agenda 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 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) 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 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: 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. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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