Speakers

Lisa Benaise


Vice President, Head of Pharmacovigilance - Calliditas Therapeutics





Lisa Benaise

Sessions


  • Tuesday - November 23, 2021 - 15:20

    Fireside Chat: Strengthening Risk Evaluation and Mitigation Strategies (REMS)

    • Creating a REMS Industry-Wide Standardized Risk Evaluation and Mitigation Strategy (REMS) Program
    • Global regulatory developments
    • EU GVP XVI revision – what we could expect?
    • REMS for generics
    • Effective tools and strategies to improve REMS effectiveness
    • REMS at the patient-level: improving safety and proper use of medicines
    • Evolving REMS: New opportunities for branded drugs 
    • What have we learned? Next steps toward the future 

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