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Tokyo Big Sight

2017 年 11 月 12 日 9:30 上午 - 2017 年 11 月 14 日 5:30 下午

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

14th DIA Japan Annual Meeting 2017

[V1-S6] Optimal Use Guidelines (Future Direction of the System, Discussion of the NDA Review Process, and Status of Actual Medical Practice)

Session Chair(s)

Yuji  Kashitani

Yuji Kashitani

Senior Director, Regulatory Policy&Innovation

Takeda , Japan

Discussion on the direction toward the official introduction of ‘Optimal Use Guidelines’ being in trial operation from FY2016. This session will discuss including the future issues, the target products planned for the Guidelines, impact on creating NDA dossiers or review for NDA approval when introduced the Guidelines, or any change or impact to the actual medical practice when Guidelines are introduced.

Speaker(s)

Eri  Sugiyama, MS

About a Background and a Summary of Optimal Clinical Use Guidelines

Eri Sugiyama, MS

Ministry of Health, Labour and Welfare (MHLW), Japan

Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Heal

Hiroyuki  Muta

Optimal Use Guidelines : from the Viewpoints of Pharmaceutical Industry

Hiroyuki Muta

Ono Pharmaceutical Co., Ltd., Japan

Senior Director, Regulatory Management

Makoto  Tahara, MD, PhD

Optimal Use Guidelines: Impact on Medical Practice

Makoto Tahara, MD, PhD

National Cancer Center Hospital East, Japan

Head and Neck Medical Oncology

Yasuhiro  Fujiwara, MD, PhD

Yasuhiro Fujiwara, MD, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Chief Executive

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