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Session 6 Track B: Towards a Structured, Criteria-Based, and Transparent Regulatory Decision-Making: A Brainstorming Session
Session Chair(s)
Marc Poitras, PhD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
Evidence-based decision-making is common to both healthcare and regulatory decisions. However, the decision-making process and criteria may not be clear to the relevant stakeholders. This session aims to bring together pre- and post-market regulatory expertise and academic expertise in Evidence-based medicine in an exchange of ideas to explore the potential for furthering regulatory decision-making methodologies.
Speaker(s)
Mohammed Toseef Ansari, MD, MS, MSc
Senior Scientific Evaluator, Health Canada/Marketed Health Products Directorate, Canada
Hydrochlorothiazide and the Risk of Non-melanoma Skin Cancer: a Signal Assessment Using the GRADE Approach
Jan Brozek, MD, PhD
Associate Professor, Health Research Methods, Evidence, and Impact, McMaster University, Canada
Speaker
Jeremy Jokinen, MS
Vice President Global Patient Safety, Argenx, United States
Speaker
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