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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
Session 8, Track B: Focusing on What Matters Most: Operationalizing Critical-to-Quality Factors in Clinical Research
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)