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[V7-S1] Call for Abstract Session
Session Chair(s)
Junko Sato, PhD
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Koichiro Yuji, MD, PhD, FACP
Project Associate Professor, The Institute of Medical Science
Japan
Three researches, two for oncology disease area and one for cardiovascular disease area, wide range of challenges in drug development in Japan, such as a promoting early stage clinical development, efficient usage of global development and optimization of postmarketing activities. Various approaches to address these challenges will be presented and comprehensive discussion will be held. 1. Characterization of toxic reactions of oncology development products observed in Japan phase 1 studies. 2. Determination of affecting factors in drug lag (gap of approval timing) between western counties and Japan in oncology drug development. 3. Medical data base research for evaluation of safety profile in antithrombotic agents
Speaker(s)
"Do all patients in the phase I trials need to be hospitalized? - Domestic but outstanding issues for globalization in Japan - "
Akihiko Shimomura, MD
National Cancer Center Hospital, Japan
Attending Staff, Dept. of Experimental Therapeutics/Breast and Medical Oncology
Meaningful Use of DPC Claim database for Postmarketing Surveillance of New Drugs
Masahiro Inoue, MD, PhD
Ota Memorial Hospital, Japan
Division Manager
Study on Drug Lag between Japan and the US in Oncology Drugs. Considerations of Changes and Factors Affecting Difference with the US
Hideki Maeda, PhD
Meiji Pharmaceutical University, Japan
Professor, Department of Regulatory Science