Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

TFT Halls & Rooms

Nov 06, 2013 9:00 AM - Nov 06, 2013 1:00 PM

TFT Building, 3-6-11 Ariake, , Koto-ku,, Tokyo, 135-8071 Japan

Advanced Regulatory Affairs Training Course in Japan

Speakers

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.

Satoshi  Fukunaga, PhD

Satoshi Fukunaga, PhD

, UCB Japan Co., Ltd., Japan

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.

Yoshikata  Furuya, MSc

Yoshikata Furuya, MSc

Manager, General Affairs Division, Sankeien Hoshoukai Foundation, Japan

Yoshikata Furuya was Director of Vaccine Policy at MSD K.K. In this position, he was responsible for developing and executing policy strategies and action plan for MSD vaccines. Yoshikata Furuya had over 25 years' experience in the pharmaceutical and biotech industries including marketing, regulatory affairs and health policy.

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.

Kiyohito  Nakai, PhD

Kiyohito Nakai, PhD

Director, Pharmaceutical Safty Division, Ministry of Health, Labour and Welfare (MHLW), Japan

Junichi  Nishino, MSc, RPh

Junichi Nishino, MSc, RPh

Head, Regulatory Affairs Department, Otsuka Pharmaceutical Co., Ltd., Japan

Junichi Nishino is Head of Regulatory Affairs at Otsuka Pharmaceutical Co., Ltd.. In this position, Junichi is responsible for leading all regulatory activities the whole world. Junichi has over 20 years' experience of regulatory affairs in the pharmaceutical industries, including Regulatory CMC, NHI pricing and Promotion compliance. Junichi holds a master degree of Pharmacy and Pharmacist licence. Junichi is currently Vice-chair of DIA Advisor Council of Japan, and is also the DIA Outstanding Service Award winner in 2014.

Norikazu  Takahata

Norikazu Takahata

President, Plus Action for Children, Japan

Nao  Tsuchida, MD, PhD

Nao Tsuchida, MD, PhD

Chief, National Hospital Organization Headquarters, Japan

Yoshiaki  Uyama, PhD, RPh

Yoshiaki Uyama, PhD, RPh

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a visiting professor in Chiba University and Nagoya University.

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.