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Global Labeling Conference

Session 5: Latin America, Middle East, and Africa Labeling Updates

    Session Chair(s)
      Gerrit  Nijveldt, MSc

      Gerrit Nijveldt, MSc

      • Senior Director of Labeling
      • Sanofi US, United States
    This session will discuss the requirements for labeling submission and regulatory agency approval in the Latin America and Middle East/Africa regions. Labeling strategies, including the use of shared labeling processes within some of the Latin American and Middle East/Africa countries, and the use and need for approved reference labeling prior to submission to agencies in some of the countries will be explored.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe labeling regulations for the LATAM and Africa/Middle East regions
    • Discuss labeling for Deferred Action countries
      Olga  Lucia Anzola

      Labeling in LATAM Region

      Olga Lucia Anzola

      • Head Center of Expertise Labeling LATAM
      • Sanofi, Colombia
      Nathalie  Cunha-Da-Silva

      Labeling in Africa/Middle East Region

      Nathalie Cunha-Da-Silva

      • Management Associate, Regulatory Excellence & Countries Management, Africa
      • Sanofi, France