Course Description

This web seminar provides a comprehensive overview of the FDA’s June 2024 draft guidance on Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections. Participants will gain insights into the key elements of BIMO inspections, including types of inspections, communication best practices, and post-inspection procedures. The course will equip attendees with strategies for preparing for and managing FDA inspections effectively.

Learning Objectives

• Identify types of BIMO inspections and their purposes in FDA-regulated research
• Explain the role of Remote Regulatory Assessments in BIMO oversight
• Discuss expectations for communication before, during, and after an inspection
• Examine BIMO processes and practices and publicly available resources
• Review relevant sections of the FDA’s Investigations Operations Manual (2024)

Who Should Attend

• Clinical Trial Managers
• Regulatory Affairs Specialists
• Quality Assurance Managers
• Clinical Research Coordinators
• Principal Investigators
• Compliance Officers
• Clinical Operations Directors
• CRO Project Managers
• Institutional Review Board (IRB) Administrators

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Registration Fees

$835*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-023-L99-P. Released: 2/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.