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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V7-S5] Pharmacovigilance Activities in Japan, the USA, and Europe - How to Utilize Real World Data -

Session Chair(s)

Hisashi  Urushihara, DrPH

Hisashi Urushihara, DrPH

Professor, Faculty of Pharmacy, Department of Pharmacy

Keio University, Japan

The 2018 GPSP revision allows the marketing authorization holders to select database studies including EHRs, claims records, and registries as the pharmacovigilance activities in Japan, changing the post-marketing regulatory climate. This session introduces the actual examples of effective use of real world data (RWD) in Western countries for the purpose of pharmacovigilance and discuss the challenges and policies to make effective use of RWD available in Japan.


Hisashi  Urushihara, DrPH


Hisashi Urushihara, DrPH

Keio University, Japan

Professor, Faculty of Pharmacy, Department of Pharmacy

Gerald  Dal Pan, MD, MHS

Effective Use of RWD in FDA for Pharmacovigilance

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Agnès  Saint-Raymond, DrMed

Effective Use of RWD in EMA for Pharmacovigilance

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

Takashi  Ando

Effective Use of RWD in PMDA for Pharmacovigilance

Takashi Ando

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Office of Medical Informatics and Epidemiology