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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S24] Have You Already Had a Labeling with New Format? How to Read New Format of Labeling and Impact for Implementation on Medical Practice

Session Chair(s)

Hideo  Nakada, RPh

Hideo Nakada, RPh

  • Assistant Professor, Division of Hospital Pharmacy Science
  • Keio University, Japan
In April 2019, the official guidelines for the new labeling format came into force, and certain specific products with labeling in line with these new guidelines have actually begun to reach the medical field. This session will present practical examples of actions taken by pharmaceutical companies in response to these guidelines, their impact on other materials (interview forms, etc.), the impact of delivering products with labeling in this new format, and points to consider when reading labeling in this new format. We will also discuss how information should be disseminated and how to provide information to advance use of the new labeling format in future medical practice.

Speaker(s)

Natsumi  Kinoshita

Points of New Format of Labeling and Impact on Other Materials

Natsumi Kinoshita

  • Reviewer, Office of Conformity Audit
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Naoto  Tone

Company Initiatives in Delivery of Labeling with New Format to Medical Practice

Naoto Tone

  • Regulatory Scientist, Regulatory
  • Eli Lilly Japan K.K., Japan
Yuuki  Sasaki

Impact for Delivery of Labeling with New Format on Medical Practice from Pharmacists of Medical Institute Perspective

Yuuki Sasaki

  • Chief, Pharmaceutical Department
  • Nihon University Hospital, Japan
Yukio  Ikejima

Impact of New Format PI for Other Materials

Yukio Ikejima

  • Japan and Asia Pharmacovigilance Department, CMA HQ
  • Eisai Co., Ltd., Japan