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Tokyo Big Sight

Nov 16, 2014 9:00 AM - Nov 16, 2014 10:30 AM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation

Speakers

Fumiaki  Kobayashi, PhD

Fumiaki Kobayashi, PhD

President, CTD inc., Japan

Dr. Fumiaki Kobayashi is the president of CTD inc. Prior to founding CTD inc., in 2010, he belonged to the PMDEC (The Pharamceutical and Medical Device Evaluation Center) from 1997 to 2000, the OPSR (Organization for Pharmaceutical Safety and Research) from 2000 to 2002, the MHLW from 2002 to 2003. During these periods, he mainly engaged to evaluate and consult for new drugs. After, he joined the JMACCT (The Japan Medical Association Center for Clinical Trials) to create and operate IIT (Investigator Initiate Clinical Trials) and to lead the organization from 2004 to 2010.

Haruko  Yamamoto, MD, PhD

Haruko Yamamoto, MD, PhD

Executive Director, National Cerebral and Cardiovascular Center, Japan

Dr. Haruko Yamamoto, a specialist in neurology, is now the Executive Director at the National Cerebral and Cardiovascular Center (NCVC), where she also serves as the Director of the Dept. of Data Science and the Dept. of Clinical Trial Management. She has led several investigator-initiated clinical studies evaluating new drugs and high-risk medical devices. After leading the academic research organization at NCVC for over ten years, she was appointed Chief Medical Officer/ Associate Executive Director at the Pharmaceutical and Medical Devices Agency til 2023. She serves as the chair of the DIA Advisory Council of Japan and a member of the Medical Device Symposium program committee. Dr. Yamamoto holds a PhD in medicine from Osaka University.

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