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Biography:

Associate Professor Division of Pharmaceutical Medicine Kitasato University Graduate School of Pharmaceutical Sciences Tokyo, Japan Dr. Mamoru Narukawa graduated from the Tokyo University, Faculty of Pharmaceutical Sciences, and joined the New Drugs Division, Ministry of Health and Welfare in 1991.Since then he has experienced several posts concerning new drug review/approval, Good Clinical Practice regulation/inspection, and medical insurance including drug price system. In the meantime, in 1994, he was temporarily transferred to the US Food and Drugs Administration and spent several months in the Division of Biostatistics in CDER. In the field of ICH, he had been a member of Expert Working Groups for several ICH Efficacy Topics. He assumed the current position of the Associate Professor in the Division of Pharmaceutical Medicine, Kitasato University Graduate School of Pharmaceutical Sciences in April 2007. His research areas include new drug development strategy, design and analysis of clinical trials, and pharmaceutical regulation. He has also been the Program Officer for Clinical & Translational Research in CSTP (Council for Science and Technology Policy) Coordination Program of Science and Technology Projects in Japan Science and Technology Agency (JST) from 2007 to 2010.