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東京ビッグサイト

2017年11月12日 (日) 午前 9:30 - 2017年11月14日 (火) 午後 5:30

〒135-0063, 東京都江東区有明3-11-1

第14回DIA日本年会

[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

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)

Emiko  Kondo, PhD

Drug Safety Measures in Japan

Emiko Kondo, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Office Director, Office of Safety II

Robert  Reynolds, DrSc, MSc, FISPE

Post-Marketing Safety Measures in the United States

Robert Reynolds, DrSc, MSc, FISPE

Pfizer Inc, United States

Vice President, Epidemiology, Worldwide Regulatory and Safety

Peter  Bachmann

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

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