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Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs
Session Chair(s)
Mary Thanh Hai, MD
Deputy Director for Clinical, OND, CDER
FDA, United States
This session is focused on sharing experience with E19 implementation from multiple stakeholders to identify successes and challenges.
Learning Objective : Describe development of E19 and principles of selective safety data collection; Discuss experiences with E19 implementation from different perspectives; Identify FDA initiatives to promote broader use of E19.
Speaker(s)
EMA Update
Priya Bahri, PhD, RPh
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
Health Canada Update
Fannie St-Gelais, PhD
Health Canada, Canada
Manager, Health Product and Food Branch
Industry Update
Anastasia Lesogor, DrMed
Novartis Pharma AG, Switzerland
Senior Global Program Clinical Program Head
FDA Update
Eileen Craig, DrMed
FDA, United States
Clinical Lead , DDLO, OCHEN, OND, CDER
Implementing Selective Safety Data Collection/E19 More Broadly
Kevin Bugin, PhD, MS, RAC
Amgen, United States
Associate Vice President, Global Regulatory Policy
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