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From Safety Signal to B/R Assessment : Impacts on PSURs/PBRERs and RMPS
Session Chair(s)
Barbara De Bernardi, MD
EUQPPV Vice President - Head of Global QPPV Office
Pfizer S.r.l., Italy
Speaker(s)
Signal Management - Signal detection, validation/evaluation - Risk determination for New EU-RMPs
Craig Hartford, MD, PhD, MSc
Pfizer, United Kingdom
VP, Safety Surv & Risk Management, Worldwide Safety & Regulatory, W R&D
From PSURs to PBRERs - Focus on special challenges (e.g. off label use, effectiveness, transparency) - PRAC Interactions/ experiences
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
RTI Health Solutions, Spain
Vice President, Global Head Epidemiology
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