Course Description

This web seminar will review the FDA’s February 2025 updates to its guidance for Institutional Review Boards (IRBs) and clinical investigators. Learners will explore the key revisions, new regulatory expectations, and practical implications for IRB oversight and investigator responsibilities in depth, and will gain a clear understanding of compliance requirements and best practices for implementing these changes in clinical research by the end of the course.

Learning Objectives

• Identify the major updates in the FDA’s February 2025 guidance for IRBs and clinical investigators
• Explain the regulatory rationale behind the new guidance changes and their impact on clinical research oversight
• Assess how the updated guidance affects IRB review processes and nvestigator responsibilities
• Develop strategies for ensuring compliance with the revised FDA expectations in clinical trials
• Apply best practices for implementing the new guidance in institutional and investigator-led research settings

Who Should Attend

• IRB Members and Administrators
• Clinical Investigators and Study Coordinators
• Regulatory Affairs Professionals
• Research Compliance Officers
• Sponsor and Contract Research Organization (CRO) Personnel

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

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 2 hours (0.2 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#: 0778-0000-25-052-L99-P. Released: 8/25. 

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