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Global Labeling Conference


Session 2: EU Labeling Updates

    Session Chair(s)
      Megann  Looker

      Megann Looker

      • Director, EU/RoW Labelling and Advertising/Promotion
      • United Kingdom
    This session will cover the latest developments in the eLabeling arena, as well as an overview of recent guidance updates and the latest thinking on regional labeling strategy.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Understand the current environment for eLabeling
    • Understand the EU timelines for MAAs and Linguistic Review in relation to other regional requirements and how these impact on other labels
    Speaker(s)
      Deborah  Bebbington

      Introduction to the EMA Action Plan

      Deborah Bebbington

      • Vice President, Head Labeling
      • Bayer, United Kingdom
      Nisha  Modha

      Envisioning the Future of Labeling Through Digitization of Information and the Current Environment for eLabelling

      Nisha Modha

      • Regulatory Labelling Site Head - Welwyn
      • Roche Products Limited , United Kingdom
      Megann  Looker

      The EC Report on the Shortcomings of the SmPC and PIL

      Megann Looker

      • Director, EU/RoW Labelling and Advertising/Promotion
      • United Kingdom
      Hayley  Parker

      Evaluation of the SmPC and the Impact to Regional Labels

      Hayley Parker

      • Senior Director, Head of Global Labeling
      • Vertex Pharmaceuticals, United States