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Session 1 - Effective presentation of safety data on label
Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC
Pfizer R&D Japan G.K., Japan
Hyang Won Min, MSc, RPh
Vice President, Head of APAC Regulatory Affairs
Johnson & Johnson, Singapore
Speaker(s)
Development and Update of Safety Labeling - 1
Mark Collins, PhD, MBA
Opus Regulatory, United States
Principal Consultant
Development and update of safety labeling - 1
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
Evaluation of Safety Information for Labelling
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
MD, Global Safety Officer
Near-Synonymous MedDRA® Terms in Medical Product Labeling
William Gregory, PhD
Pfizer Inc, United States
Senior Director, Safety and Risk Management
Ilona Grosse-Michaelis, DrMed, MD
Bayer AG, Germany
Senior Medical Dictionary Expert
Labeling as risk communication
Philip L. Arena
Pfizer Inc., United States
Director
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