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[V2-S4] Further Perspective of Development of Medicines for RD / Pediatric
Session Chair(s)
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.
Speaker(s)
Michinori Terada, PHD
Director, Clinical Sciences, Clinical Research, Pfizer Japan Inc., Japan
Innovative Clinical Development Strategies for Rare Diseases and Pediatric Indications
Harumasa Nakamura, MD, PHD
Director of Department of Clinical Research Support, , National Center of Neurology and Psychiatry, Japan
Drug Development for Orphan Drugs by Utilization of Patient Registry Current Status and Issues of Remudy
Takashi Saito, MD, PHD
Clinical Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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