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Mandarin Oriental Washington D.C.

Jan 23, 2017 7:30 AM - Jan 25, 2017 3:15 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Pharmacovigilance and Risk Management Strategies Conference

Session 3: Changing Environments

Session Chair(s)

E. Stewart  Geary, MD

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)

E. Stewart  Geary, MD

Recent Issues with Pharmacovigilance Regulatory Compliance in Japan

E. Stewart Geary, MD

Eisai Co., Ltd., Japan

MD, Global Safety Officer

Gao  Gao, MD

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

Sajjan  Daniel, MD

Challenges with Recent Post-market Requirements in Mexico

Sajjan Daniel, MD

Shire, United States

Vice President, Global Head of Safety Surveillance Global Drug Safety

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