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Global Labeling Conference


Session 6: Impact of EU GVP Module IX on Global Labeling Goverance

    Session Chair(s)
      A. Leander  Fontaine, MD

      A. Leander Fontaine, MD

      • President
      • Pharmiceutics, LLC., United States
    This session discusses the potential implications of the safety-labeling submission requirements added to the revised EU GVP Module IX on companies’ global labeling actions, policies, and processes.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Discuss the new requirements for the timing of safety labeling variations in GVP Module IX (Rev. 1)
    • Analyze the potential impact on their company’s labeling global process
    Speaker(s)
      Barbara  Lachmann, MD

      Labeling-Related Requirements in the Revised GVP Module IX and Potential Impact on Global Labeling Processes

      Barbara Lachmann, MD

      • Senior Advisor, Center of Excellence Product Information
      • Barbara Lachmann Labeling Consulting, Germany
      Elisabethann  Wright

      The New Labeling Submission Requirements in GVP Module IX – A USA Legal Point of View

      Elisabethann Wright

      • Partner
      • Hogan Lovells International LLP, Belgium
      Shinobu  Uzu, MSc

      Panelist

      Shinobu Uzu, MSc

      • Chief Safety Officer
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Elisabethann  Wright

      Panelist

      Elisabethann Wright

      • Partner
      • Hogan Lovells International LLP, Belgium