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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



[V2-S4] Further Perspective of Development of Medicines for RD / Pediatric

Session Chair(s)

Hiroshi  Watanabe, MD, PhD

Hiroshi Watanabe, MD, PhD

Vice President

Hamamatsu University School of Medicine, Japan

Pharmaceutical companies do not encourage the development of medicines for rare diseases / pediatric etc. because it is difficult to conduct clinical trials and collect the number of Japanese patient in the clinical data package so far. This session will be discussed the possibility of further development based on utilizing disease registry, RWD, etc., Model & Simulation , Post-marketing data, and planning development strategies that utilize new regulations such as ICH E17, conditional early approval system, etc.


Michinori  Terada, PhD

Innovative Clinical Development Strategies for Rare Diseases and Pediatric Indications

Michinori Terada, PhD

Pfizer Japan Inc., Japan

Director, Clinical Sciences, Clinical Research

Harumasa  Nakamura, MD, PhD

Drug Development for Orphan Drugs by Utilization of Patient Registry Current Status and Issues of Remudy

Harumasa Nakamura, MD, PhD

National Center of Neurology and Psychiatry, Japan

Director of Department of Clinical Research Support,

Takashi  Saito, MD, PhD

Takashi Saito, MD, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Clinical Reviewer, Office of New Drug III