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Session 3: Changing Environments
Session Chair(s)
E. Stewart Geary, MD
MD, Global Safety Officer
Eisai Co., Ltd., Japan
Both mature and developing pharmaceutical markets continue to go through changes in regulations or expectations for conduct of pharmacovigilance. This session will present recent developments in Japan, China and Mexico, which are each either undergoing changes in regulations or expectations related to postmarketing pharmacovigilance and the practice of drug safety during clinical development.
Speaker(s)
Recent Issues with Pharmacovigilance Regulatory Compliance in Japan
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
MD, Global Safety Officer
Safety Aspects for An Innovative Product in Local Clinical Trials in China: The transition through registration, and post-marketing challenges
Gao Gao, MD
Pfizer China R&D Center, China
Director and Global Safety Risk Lead, Safety Surveillance and Risk Management
Challenges with Recent Post-market Requirements in Mexico
Sajjan Daniel, MD
Shire, United States
Vice President, Global Head of Safety Surveillance Global Drug Safety