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 R3revision 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.

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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.

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