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DIA 2021 Global Annual Meeting

How Can We Compliantly Exchange Pre-Approval Information with Payers

Session Chair(s)

Sissi Pham, PharmD

Sissi Pham, PharmD

  • Chief Executive Officer
  • AESARA, United States
Discuss the practical challenges with interpretation aspects of the FDA Payer guidance released in 2018 for pre-approval communications and and possible operationalization considerations.
Learning Objective : Describe how we can proactively and compliantly communicate during pre-approval phase relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Speaker(s)

Stephen Shinall, PhD

Industry Perspective

Stephen Shinall, PhD

  • Associate Director, Regulatory Affairs, US Advertising and Promotion
  • AbbVie, Inc., United States
Susan A Cantrell, RPh

Industry Update

Susan A Cantrell, RPh

  • Chief Executive Officer
  • Academy of Managed Care Pharmacy (AMCP), United States
Lucy Rose, MBA

Industry Update

Lucy Rose, MBA

  • President
  • Lucy Rose and Associates, LLC, United States