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Session 8, Track B: Critical to Quality - Operationalizing ICH E8(R1) and E6(R3): From Theory to Practice
Session Chair(s)
Rosemarie Clarke, RN, PMP
Translational & Clinical Research Consultant, AllWright-Clarke Research Solutions Inc., Canada
Hocine Abid, MD, MBA
National Manager, Regulatory Operations and Enforcement Branch, Health Canada, Canada
ICH GCP E6(R3) reframes Critical to Quality (CtQ) as a move from box checking compliance to meaningful, outcome driven quality. With the evolving expectations of global regulators, early, cross functional alignment on what is truly critical can prevent downstream issues, reduce operational burden, and improve trial efficiency. This session highlights practical approaches to integrating CtQ into protocol design and trial operations to enhance participant protection, data integrity, and study performance.
Learning Objective : At the conclusion of this session, participants should be able to - Understand how ICH GCP E6(R3) reframes Critical to Quality (CtQ) from procedural compliance to outcome driven quality
- Apply practical strategies to integrate CtQ principles
Speaker(s)
Ivy Salter, MA
Director, Clinical Research Quality Assurance, Ottawa Hospital Research Institute, Canada
From Compliance to Impact: Implementing Critical to Quality (CtQ) Under ICH GCP E6(R3)