Course Description

The release of ICH GCP E6 R3 marks a significant update to the previous versions of the guidelines, reflecting a more flexible, risk-based approach to clinical trial management. This revision enhances the framework for clinical trial design, conduct, oversight, and reporting, with an emphasis on improving trial efficiency, data integrity, and the protection of human subjects. The R3 update also refines roles and responsibilities for sponsors, CROs, and clinical investigators/sites, aligning them with current best practices and regulatory expectations. This web seminar will provide an overview of the key updates in ICH GCP E6 R3, including new definitions, sponsor/CRO and investigator responsibilities, and essential documents. We will also explore how these updates influence clinical trial processes and provide practical guidance on how to implement these changes within your organization.

Learning Objectives

• Explain the rationale behind the ICH GCP E6 R3 updates, and their intended impact on clinical trial management
• Describe the key terms and definitions that were introduced or updated in the ICH GCP E6 R3
• Identify the specific changes in the ICH GCP E6 R3 update and proposed updates impacting sponsors, CROs, and clinical investigators/sites
• Recognize the significance of these changes for sponsor/CRO and investigator/site responsibilities, and their potential impact on clinical trial conduct

Who Should Attend

• Managers/Directors: Clinical Operations, Clinical Research, Quality Management, Compliance
• Study Managers, Project Managers
• Clinical Research Associates/Monitors
• Quality Assurance Personnel

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

$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 2.5 hours (0.25 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#: 0778-0000-25-034-L04-P. Released: 4/25. 

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