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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
      Barbara  Lachmann, MD

      The Revised GVP Module IX and its Potential Impact on Global Labeling Processes - Introduction

      Barbara Lachmann, MD

      • Consultant
      • Barbara Lachmann Labeling Consulting, Germany
      Elisabethann  Wright

      Understanding the Labeling-Related Requirements of the Revised GVP Module IX

      Elisabethann Wright

      • Partner
      • Hogan Lovells International LLP, Belgium
      Lynn W. Mehler, JD

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

      Lynn W. Mehler, JD

      • Partner
      • HoganLovells, United States
      Shinobu  Uzu, MSc


      Shinobu Uzu, MSc

      • Associate Executive Director
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Deborah  Bebbington


      Deborah Bebbington

      • Vice President, Head Labeling
      • Bayer, United Kingdom
      Kiernan  Trevett


      Kiernan Trevett

      • Senior Pharmacovigilance Inspector, Enforcement and Standards
      • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
      Paula  Hudson, RPh, RAC


      Paula Hudson, RPh, RAC

      • Director, Global Labeling
      • Eli Lilly and Company, United States