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Global Labeling Conference


Session 3: US Updates

    Session Chair(s)
      Paula  Hudson, RPh, RAC

      Paula Hudson, RPh, RAC

      • Director, Global Labeling
      • Eli Lilly and Company, United States
    This session provides information on labeling-related regulatory guidances and current expectations that are essential for those involved in drafting and maintaining US labeling throughout its lifecycle.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the latest information regarding SPL expectations and upcoming changes
    • Identify best practices when developing patient labeling to prevent medication errors
    • Gain industry insights from attending the FDA REdI Conference on Prescription Drug Labeling
    • Understand the strengths and limitations for the Adverse Reaction section in US labeling
    Speaker(s)
      Herbert L O'Brien

      SPL Updates

      Herbert L O'Brien

      • Sr. Local Labeling Registration Manager
      • Bayer HealthCare Pharmaceuticals Inc., United States
      Gina M Monteiro

      Insights and Learnings from the FDA REdI Conference

      Gina M Monteiro

      • Regulatory Quality Consultant
      • Eli Lilly and Company, United States
      A. Leander  Fontaine, MD

      Adverse Reaction Section of the USPI

      A. Leander Fontaine, MD

      • President
      • Pharmiceutics, LLC., United States
      Barbara  Lachmann, MD

      Adverse Reaction Section of the USPI

      Barbara Lachmann, MD

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