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Session 1 - Part 1: Evolving Expectations for Benefit-Risk Assessment
Session Chair(s)
Lawrence Liberti, PHD, RAC
Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, United States
In this featured two-part session global regulatory and industry representatives will provide detailed updates on the key benefit-risk initiatives.
Speaker(s)
IMI PROTECT Initiative
Juhaeri Juhaeri, PHD
Sanofi, United States
Vice President and Global Head, Epidemiology and Benefit-Risk Evaluation
Update on EMA Benefit-Risk Initiatives
Hans-Georg Eichler, MD, MSC
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Health Canada’s New Benefit Harm Uncertainty (BHU) Framework
Robyn R. Lim, PHD
Health Canada, Canada
Senior Science Advisor, Health Products and Food Branch
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