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Ariake Central Tower Hall and Conference

2023年11月05日 (日) 午前 9:30 - 2023年11月05日 (日) 午後 12:45

Ariake Central Tower 3F, 4F, 3-7-18 Ariake, Koto-ku, Tokyo, 135-0063 Japan

#SC03: DIA Regulatory Communication Training


Akiko  Ikeda, RPh

Akiko Ikeda, RPh

Associate Director, Regulatory Development Dept., Janssen Pharmaceutical K.K., Japan

Education Background: Graduated Tokyo University of Pharmacy and Life Sciences / Qualification: Licensed Pharmacist / CURRENT POSITION: Senior Manager of Policy Intelligence Department in Janssen Pharma K.K (Japan), A leader of Regulatory Sub Committee in PhRMA Japan, A member of Contents Committee in DIA Japan / SUMMARY OF PROFESSIONAL EXPERIENCE: 5 years of experiences at regulatory policy and intelligence; About 20 years of experiences at regulatory affair area including development for New drugs (NDA/ PMDA consultation); Started the carrier at Sankyo Co. (Currently Daiichi-Sankyo Co.) in 1986.

Teruyo  Arato, PhD

Teruyo Arato, PhD

Professor, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Japan

She graduated Hokkaido University faculty of Pharmacy in1984 and received her Ph.D. in Medicine from the University of Tokyo in 1998. She joined the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences (Japan) in 1999. From 2005 to 2011, she was a Review Director, Office of Biologics, PMDA (Pharmaceuticals and Medical Devices Agency) . She served as the Division Director of Human Resources Development Division, Office of Regulatory Science, PMDA from 2011-2012. She is currently working as a Professor of Hokkaido University Graduate School of Medicine. She is also a member of the Health Science Council of Ministry of Health, Labour and Welfare (MHLW) and outside expert of PMDA.

Masaharu  Doi

Masaharu Doi

Medical Writer, Associate Director, ICON Clinical Research GK, Japan

Toshiko  Ishibashi, PhD, RN

Toshiko Ishibashi, PhD, RN

Oncology Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Japan

Toshiko Ishibashi is an Associate Director of Oncology Medical Science in Medical Affairs at Daiichi Sankyo Co., LTD. since 2020. She served Ono Pharmaceutical Company from 2018 to 2020. She was a Clinical Operations Manager at Abbvie, 2016-2018. She has experience as an assistant professor at the College of Nursing Art and Science, University of Hyogo. She has 16 years of clinical research experience as a Clinical Research Coordinator at Kumamoto University Hospital and St. Luke’s International Hospital.

Takaaki  Ishine

Takaaki Ishine

Senior Clinical Research Specialist, MSD K.K., Japan

Yutaka  Iwasaki

Yutaka Iwasaki

, Ministry of Health, Labour and Welfare, Japan

Yomei  Matsuoka, MSc, RPh

Yomei Matsuoka, MSc, RPh

Vice President, Pharmacoepidemiology and PMS Department, Daiichi Sankyo Co., Ltd., Japan

Mr. Matsuoka is Senior Director of Pharmacovigulance Department at Daiichi Sankyo Co., LTD. He joined Sankyo Co., LTD. in 1991, and has worked for Daiichi Sankyo Co., LTD.since 2007. After engagement in clinical development department and regulatory affairs department for over 20 years, and moved to pharmacovigilancedepartment. Currently, he is in charge of safety planning for the several therapeutic areas such as CV, oncology, CNS, vaccines and contrast agents.

Naomi  Misaki, MPharm

Naomi Misaki, MPharm

CRC, Research Management, St. Luke's International Hospital, Japan

Ms. Misaki is a manager of a research management at St.Luke's Inernational Hospital. In this position, Ms. Misaki is responsible for managing all clinical trials, IRB and research committees in the hospital. Ms. Misaki also supports research planning in the hospital. Ms. Misaki has 20 years' of experience as a CRC and as a secretary member of the IRB and Research Ethics Review Board.

Fumie  Miwa

Fumie Miwa

Senior Manager, RA Therapeutic Area Group, Oncology, Regulatory Affairs, AbbVie GK, Japan

Hiroyuki  Murakami

Hiroyuki Murakami

Duputy Review Director, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Hiroyuki Murakami is currently deputy review director, Office of New Drug I, PMDA. He is engaged in a review of drugs for metabolic disorders including daibetes mellitus, inborn errors of metabolism, etc. He joined PMDA in 2006, and he served as a reviewer of gastrointestinal disease and kidney disease drugs for about 7 years. From 2013, he had been working as a risk manager of onclogy drugs in Office of Safety II. In 2017, he moved to current position.

Akie  Nakano

Akie Nakano

Regulatory Affairs, Regulatory CMC Japan, Sanofi K.K., Japan

Norikazu  Takahata

Norikazu Takahata

President, Plus Action for Children, Japan

Nao  Tsuchida, MD, PhD

Nao Tsuchida, MD, PhD

Chief, National Hospital Organization Headquarters, Japan

Mengyan  Deng, PhD

Mengyan Deng, PhD

Senior Associate, Japan Regulatory Affairs, Eisai Co., Ltd., Japan