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Advertising and Promotion Regulatory Affairs Conference


Session 5 Track B: Building an Effective and Compliant Product Communication Strategy for Payors, Formulary Committees, and Similar Entities

    Session Chair(s)
      Sheetal  Patel, PharmD

      Sheetal Patel, PharmD

      • Head, Regulatory Advertising and Promotion
      • Johnson & Johnson International, United States
    With the advent of real world evidence and other continued evidence generation strategies of a product, building an effective and compliant product communication strategy is valuable to help payors, formulary committees, and other similar entities determine budgets and needs of their covered lives. This session will outline the current regulatory framework that allows the opportunity to communicate product information compliantly, explore the ability to effectively operationalize these efforts within an organization, and discuss future impact through regulatory reform of product communication to payors, formulary committees, and similar entities.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the current regulatory framework that governs communication with Payors, Formulary Committees, and Similar Entities
    • Discuss opportunities and tools to operationalize the draft guidance
    • Review the impact regulatory reform on product communication
    Speaker(s)
      Amy C. Van Sant, PharmD, MBA

      Speaker

      Amy C. Van Sant, PharmD, MBA

      • Director, Regulatory Advertising and Promotion
      • Johnson & Johnson, United States
      Katlin McKelvie Backfield, JD

      Speaker

      Katlin McKelvie Backfield, JD

      • Principal
      • Backfield PLLC, United States

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