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Session 1106: POST-MARKETING RESEARCHES/STUDIES-AS A TOOL FOR SAFETY
Session Chair(s)
Xiaojun GUO, PhD
Head
GlaxoSmith-Kline, China
After a drug is authorized in the market, the knowledge of its safety will continue expanding with the wide use of the drug in the real world. Post-marketing research as well as other post-marketing surveillance activities play an important role to monitor drug safety. The session will introduce the requirement of post-marketing researches from the regulatory perspective and will also discuss why and how a company should select the best suitable type of post-marketing studies to study drug safety, as well as the considerations in conducting these types of studies.
Speaker(s)
Dan Wang
CFDA- Wuxi FDA, China
Minzhu Li
Postmarketing Safety Expert, China
Postmarketing Safety Expert
Gang Cheng
CFDA, China
Assistant Director, National Center for ADR Monitor
Jingping Mo, MD, PhD
Pfizer Inc., United States
Director
Dayou WANG
Huashan Hospital, Fudan University, China
Lei Sun
GlaxoSmithKline(China) Investment Co., Ltd., China
Associate Clinical Research Manager
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