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Tokyo Big Sight

Nov 16, 2014 11:00 AM - Nov 16, 2014 12:30 PM

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

#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes!

Speakers

Shuji  Sumida, MSc, RPh

Shuji Sumida, MSc, RPh

Director, Project Quality and Risk Management, Japan

Mr. Shuji Sumida is Senior Director, HR Business Partner of Quality & Regulatory Compliance Unit at CHUGAI PHARMACEUTICAL CO., LTD. In this position, Mr. Sumida is a responsible person for HR strategy containing hiring, rotation and carrier development in that division. Mr. Sumida has over 35 years' experience in the pharmaceutical industries, including Formulation Technology, Project Management, and Quality & Regulatory Compliance. Mr. Sumida holds a MSc in Pharmacoscience from Tokyo University of Science and a Project Management Specialist from PMAJ.

Koji  Iwasaki, PhD

Koji Iwasaki, PhD

Professor, Academic Clinical Research Center, , Osaka University Hospital, Japan

Dr.Koji Iwasaki is the Professor of Academic Clinical Research Center, Osaka University Hospital. Dr. Iwasaki is incharge of progress of clinical research, specially, building the strategy, clarify the hypothesis and creating the protocol for clinical trial with investigators in reserch team. Dr. Iwasaki has over 30 years' clinical development experience in the pharmaceutical company, including clinical research and reguratory science. Dr. Iwasaki has experience in setting up medical affairs departments in pharmaceutical companies and he is the organizer of the Medical Affairs Certification Training Program of the Regulatory Science Foundation. Dr. Iwasaki holds a PhD in Pharmaceutical science from Kyoto Pharmaceutical University.

Atsushi  Tsukamoto, PhD, MSc

Atsushi Tsukamoto, PhD, MSc

Head is Therapeutic Area Strategies , Daiichi Sankyo, United States

Atsushi is the Corporate Officer and Head of Therapeutic Area Strategy in Daiichi Sankyo, to manage multiple therapeutic area strategy. Prior to that, he was VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He has been global project manager for nearly 20 years (in JPN & US) and the head of PM office in Daiichi Sankyo Japan for 3 years. He has been an active volunteer to both DIA global and Japan, playing session chair roles in global annual meeting more than 10 times, and was the vice-chair for 13th DIA Japan Annual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.

Yoko  Kazami, RPh, PMP

Yoko Kazami, RPh, PMP

Director, Regulatory Affairs, Nobelpharma Co., Ltd., Japan

Yoko Kazami is a project manager, who has worked for Nobelpharma Co., Ltd. from January 2017. She has over 15 years' experience in Japanese pharmaceutical companies and Academia research organizations. She is also a member of DIA Project management community in Japan, and plans and conducts some PM training course. She obtained her B.S. in Pharmacy from Showa University, 1997.

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