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Tokyo Big Sight

2018 年 11 月 11 日 9:30 上午 - 2018 年 11 月 13 日 5:40 下午

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

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[V2-S1] Changes Required for Risk Minimization Materials

Session Chair(s)

Mamoru  Narukawa, PHD, RPH

Mamoru Narukawa, PHD, RPH

Professor, Kitasato University, Japan

It has been 5 years since the RMP was implemented in Japan. The risk minimization measure, which is vital in considering the RMP as well as the Benefit Risk balance, is becoming more important. With regard to materials for healthcare professionals and for patients which have been part of the risk minimization measure in Japan, this session will discuss the direction of changes required in the future, based on current issues.

Speaker(s)

Kazuhiko  Ishida, MSC, RPH

Kazuhiko Ishida, MSC, RPH

Director, Pharmacovigilance, Astellas Pharma Inc., Japan

Points to Consider for Implementation of Risk Minimization Materials

Masahiro  Hayashi, PHD

Masahiro Hayashi, PHD

Pharmaceutical affairs specialist, Department of Pharmacy, Toranomon Hospital, Japan

Recognition and Expectation of Hospital Pharmacists on Risk Minimization Materials

Asami  Ezaki, PHD

Asami Ezaki, PHD

Division Director, PR Section, Office of Planning and Operations, Pharmaceuticals and Medeical Devices Agency (PMDA), Japan

Current Status and Future of Information Providing Materials for Risk Minimization

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