Course Description

The ICH GCP E6 R3 update refines the focus on quality management in clinical trials, shifting towards a more structured and risk-based approach to trial oversight. Building on the previous guidance from E6 R2, the R3 revision emphasizes the importance of a Clinical Quality Management System (cQMS) to ensure quality throughout the entire clinical trial lifecycle—from design through to archiving. This web seminar will explore the sponsor’s responsibilities in implementing and maintaining a risk-based quality management system, highlighting new requirements introduced in E6 R3. Industry benchmarks, standards, and best practices for establishing cQMS, as well as practical approaches to achieve compliance will also be covered. Additionally, the web seminar will address the implications of the R3 updates, including how these changes influence risk management and trial quality oversight.

Learning Objectives

• Describe two new requirements for sponsor quality management (QM) in clinical trials as outlined in ICH GCP E6 R3
• Identify two risk-based approaches to achieving compliance with QM throughout the clinical trial lifecycle
• Determine next steps for evaluating and implementing the new quality management requirements in clinical trials

Who Should Attend

• Trial Managers
• Project Managers/Directors
• Clinical Quality Assurance/Compliance Personnel

Instructor

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

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

Shelia Russell McCullers, M.S., D.M.

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#: 0778-0000-25-035-L99-P. Released: 2/25. 

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