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14th DIA Japan Annual Meeting 2017

[V3-S2] [Educational Session] Understand the Rules and Process of the US and EU Labeling

    Session Chair(s)
      Rie  Matsui, RPh

      Rie Matsui, RPh

      • Director, Regional Labeling Head for Asia, International Labeling Group
      • Pfizer Japan Inc., Japan
    Centralized labeling within global companies has been further facilitated by MRCT progress. It is necessary to revisit the rules of US and EU labeling to identify the difference between the US/EU and Japan in order to properly understand the global headquarters’ intention. Moreover, the ruling process such as US PRA or CBE, and EU labeling process such as CP or MRP will be discussed for greater understanding. This session is important for people who are actually involved in the division of labeling management, as well as for people in divisions related to the new drug development.
      A. Leander  Fontaine, MD

      Regulatory Procedures for Changing the Content of Healthcare Professional Labeling and Associated Patient Labeling: USA

      A. Leander Fontaine, MD

      • President
      • Pharmiceutics, LLC., United States
      Francesco  Pignatti, MD

      Rules and Processes of the EU Labelling

      Francesco Pignatti, MD

      • Head of Oncology, Haematology, Diagnostics
      • European Medicines Agency (EMA), United Kingdom

Contact us

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

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