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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)
Priya Bahri, PHD
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
EMA Update
Fannie St-Gelais, PHD
Manager, Health Product and Food Branch, Health Canada, Canada
Health Canada Update
Anastasia Lesogor, DrMed
Senior Global Program Clinical Program Head, Novartis Pharma AG, Switzerland
Industry Update
Eileen Craig, DrMed
Clinical Lead , DDLO, OCHEN, OND, CDER, FDA, United States
FDA Update
Kevin Bugin, MS, RAC
Head of Global Regulatory Policy and Intelligence, Amgen, United States
Implementing Selective Safety Data Collection/E19 More Broadly
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