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14th DIA Japan Annual Meeting 2017

[V3-S3] What Needs to Be Done for Creating Labeling Based on the New Revision of Items to be Included?

    Session Chair(s)
      Ken  Nakajima, RPh

      Ken Nakajima, RPh

      • Deputy Head of Medical Safety, Pharmacovigilance Department
      • Otsuka Pharmaceutical Co., Ltd., Japan
    The Japan labeling regulations has been amended for the first time in 20 years and will be implemented in 3 years, which means that each company needs to prepare labeling according to the new revision of the labeling regulations. In order to do so, various preparations including verification of rationale of the current items and review of the latest data may be needed. In this session, PMDA will provide details on not just the summary of the new revision of items to be included, but points to be practically considered from the standpoint of PMDA. Also, as we need to observe our reality, action items will be picked up from a corporate perspective and will be discussed. The best practices and challenges for revision of labeling should be shared and discussed. A speaker from multinational companies will describe points to be considered as foreign-based companies, especially how to proceed this project including the communication between HQ. In addition, a difference in approach between foreign-based companies and domestic HQ companies will be discussed.
      Akifumi  Kamata, PhD

      Points to Revision of Package Inserts Based on the New Revision of Guide to Drafting Package Inserts -from the Standpoint of PMDA-

      Akifumi Kamata, PhD

      • Reviewer, Office of Safety II
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Hanako  Saito

      Discussion of Best Practice and Challenges for Revision of Labeling

      Hanako Saito

      • Senior Director, Safety and Risk Management Dept., Safety Information Mgmt Group
      • Daiichi Sankyo Co., Ltd., Japan
      Jun  Ishikawa

      Issues and Solutions for Addressing the New Revision of Guide to Drafting Package Inserts -from the Standpoint of Global Company-

      Jun Ishikawa

      • Japan Team Lead, International Labeling Group Asia, Regulatory Affairs
      • Pfizer Japan Inc., Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313