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[V7-S5] Pharmacovigilance Activities in Japan, the USA, and Europe - How to Utilize Real World Data -
Session Chair(s)
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.
Speaker(s)
Hisashi Urushihara, DrPH
Professor, Faculty of Pharmacy, Department of Pharmacy, Keio University, Japan
Introduction
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Effective Use of RWD in FDA for Pharmacovigilance
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
Effective Use of RWD in EMA for Pharmacovigilance
Takashi Ando
Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Effective Use of RWD in PMDA for Pharmacovigilance