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[V3-S1] [Educational Session] Comparison of Post-Marketing Safety Measures among Japan, the U.S. and the EU – From the Point of View of Risk Management -
Session Chair(s)
Yomei Matsuoka, MSc, RPh
Vice President, Pharmacoepidemiology and PMS Department
Daiichi Sankyo Co., Ltd., Japan
As multi-regional clinical trials increase, global application and approval and elimination of drug lag are about to be realized, while data of clinical trials in each country tend to decrease compared to before the implementation of multi-regional clinical trials. Therefore, the importance of safety measures in post-marketing phase are relatively increasing for clarifying details of drug safety and efficacy profiles in timely manner. In this context, we will share the difference in concept of risk management between Japan, the U.S., and the EU and the current status and challenges of post-marketing safety measures during this educational session.
Speaker(s)
Drug Safety Measures in Japan
Emiko Kondo, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of Safety II
Post-Marketing Safety Measures in the United States
Robert Reynolds, DrSc, MSc, FISPE
Pfizer Inc, United States
Vice President, Epidemiology, Worldwide Regulatory and Safety
Post-Marketing Surveillance and Safety Measures in the EU
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Deputy-Head, European Union and International Affairs