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This web seminar provides a comprehensive overview of the FDA’s June 2024 draft guidance on Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections.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 at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

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.