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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[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.


Yasuyuki  Katayama, MD, PhD

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

Yasuyuki Katayama, MD, PhD

Pfizer Japan Inc., Japan

Corporate Officer, Country Medical Director and Head of Medical Japan

Tokuo  Tanaka

Initiatives Toward Appropriate Advertisement Activities in JPMA

Tokuo Tanaka

Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Managing Director

Makoto  Shiragami, PhD

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

Makoto Shiragami, PhD

Teikyo Heisei University, Japan

Professor, Faculty of Pharmaceutical Sciences

Takamasa  Horio, JD

Guidelines on Pharmaceutical Product Communications

Takamasa Horio, JD

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

Legal Advisor, Compliance and Narcotics Division

Kunio  Kawajiri

Kunio Kawajiri

Astellas Pharma Inc., Japan

Healthcare Compliance Group, Ethics & Compliance Department

Kana  Matsumura

Kana Matsumura

Sanofi K.K., Japan

Legal Counsel, Legal