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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
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Health Canada Update
Manager, Health Product and Food Branch, Health Canada, Canada
Industry Update
Senior Global Program Clinical Program Head, Novartis Pharma AG, Switzerland
FDA Update
Clinical Lead , DDLO, OCHEN, OND, CDER, FDA, United States
Implementing Selective Safety Data Collection/E19 More Broadly
Head of Global Regulatory Policy and Intelligence, Amgen, United States
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