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Risk-Based Quality Management in Clinical Trials: From the Vision to Its Regulation and Implementation
Session Chair(s)
Anabela Marcal, PharmD
EMA Liaison Official to the US FDA
European Medicines Agency, Netherlands
This session will provide an overview on the regulator’s vision to risk-based approaches and how some of these expectations are intended to be regulated through the ICH E6 GCP guideline and the challenges faced by industry in translating those expectations in the design and conduct of clinical trials.
Learning Objective : Provide an overview of the regulator’s vision on the risk-based approaches to clinical trials; Provide information on the progress with the addendum to the ICH E6 guideline; Discuss examples of approaches of implementation strategies to translate regulatory expectations into actual clinical trial conduct.
Speaker(s)
Panelist
Ni Aye Khin, MD, MS
FDA, United States
Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
Panelist
Stephanie Shapley, MBA
FDA, United States
Associate Director for Regulatory Affairs, OMPI, OMP, CDER
Panelist
Ann Meeker-O'Connell, MS
Novartis, United States
Executive Director, Monitoring Excellence Head
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