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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



[V6-S6] Evidence Generation under Japan’s New Clinical Trials Act

Session Chair(s)

Shinzo  Hiroi, PhD, MPH, RPh, PMP

Shinzo Hiroi, PhD, MPH, RPh, PMP

Head of Global Medical Affairs

Shionogi & Co., Ltd., Japan

It would become more complicated to conduct interventional studies due to new clinical trials act, effective in April 2018 in Japan. The importance of observational studies has been focused to generate the medical evidence originated from Japan. In this session, the advantages and limitations of observational studies will be discussed, compared with those of interventional studies.


Akihito  Uda, MPH

Case Studies of Real World Evidence in HEOR of Pharmaceutical Industry

Akihito Uda, MPH

Novartis Pharma K.K., Japan

HEOR Group, Market Access and Public Affairs Division

Koji  Iwasaki, PhD

Impact of Clinical Trial Act on Generating Medical Evidence

Koji Iwasaki, PhD

Osaka University Hospital, Japan

Professor, Academic Clinical Research Center,

Hisashi  Urushihara, DrPH

Basics of Observational Study

Hisashi Urushihara, DrPH

Keio University, Japan

Professor, Faculty of Pharmacy, Department of Pharmacy