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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.

[V4-S4] It’s Time to Think About Compliance to Deliver Value Added Medical Information - Current and Ideal Situation of Medical Iformation Provision

Session Chair(s)

D. Stuart  Sowder, JD, PHARMD, MBA

D. Stuart Sowder, JD, PHARMD, MBA

Vice President, Compliance Lead, Asia, Pacific, Africa, Middle East, Pfizer Holdings, United States

Following the daily changing scientific and ethical approach, data building that collected our wisdom will be the basis of application for approval. How should we provide the approved data to health care professionals and contribute to the improvement of medical quality? The advertisement activity surveillance monitor system began and entered the second year. It seems that the time has come when we must consider for our actions and ethical standards together with our stakeholders instead of considering the compliance by a single organization. In this session, we are going to discuss the current or future direction in Japan following global trend regarding medical information provision with compliance experts from each pharmaceutical association (JPMA, PhRMA, EFPIA), academia and regulatory authority.

Speaker(s)

Yasuyuki  Katayama, MD, PHD

Yasuyuki Katayama, MD, PHD

Corporate Officer, Country Medical Director and Head of Medical Japan, Pfizer Japan Inc., Japan

It’s Time to Think About Compliance to Deliver Value Added Medical Information -Current and Ideal Situation of Medical Information Provision-

Tokuo  Tanaka

Tokuo Tanaka

Managing Director, Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Initiatives Toward Appropriate Advertisement Activities in JPMA

Makoto  Shiragami, PHD

Makoto Shiragami, PHD

Professor, Faculty of Pharmaceutical Sciences, Teikyo Heisei University, Japan

Problems of Drug Promotion Activities Emerging from Report from Advertisement Surveillance Monitoring

Takamasa  Horio, JD

Takamasa Horio, JD

Legal Advisor, Compliance and Narcotics Division, Ministry of Health, Labour and Welfare (MHLW), Japan

Guidelines on Pharmaceutical Product Communications

Kunio  Kawajiri

Kunio Kawajiri

Healthcare Compliance Group, Ethics & Compliance Department, Astellas Pharma Inc., Japan

Kana  Matsumura

Kana Matsumura

Legal Counsel, Legal, Sanofi K.K., Japan

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