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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S10] Initiatives For The Future of Digital Health: Utilizing Digitalized Product Information/Labeling for Healthcare Professionals and Patients

Session Chair(s)

Rie  Matsui, RPh

Rie Matsui, RPh

  • Senior Director, Regional Labeling Head for APAC
  • Pfizer R&D, Japan
Digitalized product information, part of the evolving global movement toward digitalization of healthcare, can improve health literacy for patients and enable patients to choose their own healthcare more proactively. Per the revised regulation for labeling implemented in April 2019, XML conversion has been required for labeling information in Japan. XML converted labeling, already implemented in the US, is the backbone of digitalized product information; other western countries have also started to consider XML conversion of labeling. This session will look ahead to the future of digital health by comparing these initiatives in Japan, the US, and the EU, and discussing utilization of digitalized product information/labeling issued by regulatory authorities and companies for patients and healthcare


Peter  Bachmann

The Electronic Product Information (ePI)-Initiative of the European Union

Peter Bachmann

  • Deputy-Head, European Union and International Affairs
  • Federal Institute for Drugs and Medical Devices (BfArM), Germany
Takashi  Tai

Current Situation and the Future of e-Labeling Utilization in Japan from Regulator’s Point of View

Takashi Tai

  • Deputy Director, Pharmaceutical Safety and Environmental Health Bureau
  • Ministry of Health, Labour and Welfare (MHLW), Japan
Shimon  Yoshida, PhD

Advancements in e-labeling technologies and their global implementation

Shimon Yoshida, PhD

  • Executive Director, International Labeling Group, Global Regulatory Affairs
  • Pfizer Inc, United Kingdom