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[V6-S6] Evidence Generation under Japan’s New Clinical Trials Act
Session Chair(s)
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.
Speaker(s)
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
Impact of Clinical Trial Act on Generating Medical Evidence
Koji Iwasaki, PhD
Osaka University Hospital, Japan
Professor, Academic Clinical Research Center,
Basics of Observational Study
Hisashi Urushihara, DrPH
Keio University, Japan
Professor, Faculty of Pharmacy, Department of Pharmacy