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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S21] What Kind of Information Should Medical Deliver in Compliance with Promotional Activity Guideline?

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
MHLW issued “the Guidelines on Pharmaceutical Product Communications” and “the matters related to the supervisory division of Pharmaceutical Product Communications” on 1st April 2019 and 1st October 2019 respectively. Also, JPMA issued Consensus Statement for MA/MSL on 1st April. These mean Medical is now required to have proper information provision with higher ethics and transparency than ever. Currently, many pharmaceutical companies are implementing various actions or governance process to meet with MHLW guideline. In this session, speakers will share practices or lessons learned about the operation with understanding of MHLW guideline or Consensus Statement of MA/MSL. During this session, we will be able to clarify information Medical should deliver in compliance with guideline.


Takamasa  Horio, JD

A Practical Approach to the Guidelines on Pharmaceutical Product Communications

Takamasa Horio, JD

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

Implementation of Sales Information Provision Guidelines in Pharma Companies

Kana Matsumura

  • Legal Counsel, Legal
  • Sanofi K.K., Japan
Yasuyuki  Katayama, MD, PhD

Pfizer Japan’s New Governance and QMS for MHLW Promotion GL

Yasuyuki Katayama, MD, PhD

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