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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)
Hydrochlorothiazide and the Risk of Non-melanoma Skin Cancer: a Signal Assessment Using the GRADE Approach
Mohammed Toseef Ansari, MD, MS, MSc
Health Canada/Marketed Health Products Directorate, Canada
Senior Scientific Evaluator
Speaker
Jan Brozek, MD, PhD
McMaster University, Canada
Associate Professor, Health Research Methods, Evidence, and Impact
Speaker
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences