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Virtual

Jun 27, 2021 10:00 AM - Jul 01, 2021 4:30 PM

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

Biogen, United States

Director of Regulatory Affairs

Susan A Cantrell, RPh

Industry Update

Susan A Cantrell, RPh

Academy of Managed Care Pharmacy (AMCP), United States

Chief Executive Officer

Lucy  Rose, MBA

Industry Update

Lucy Rose, MBA

Lucy Rose and Associates, United States

President

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