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Bethesda North Marriott Hotel and Conference Center

08 mar 2018 7:00 a.m. - 09 mar 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

Vice President, Specialty Compliance

Johnson & Johnson, 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  • Discuss opportunities and tools to operationalize the draft guidance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  Van Sant, PharmD, MBA

Operationalizing an Effective and Compliant Product Communication Strategy

Amy Van Sant, PharmD, MBA

Inizio Engage, United States

President, Medical Affairs

Katlin McKelvie Backfield, JD

Legal Framework and Regulatory Outlook

Katlin McKelvie Backfield, JD

Backfield PLLC, United States

Principal

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