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How Can We Compliantly Exchange Pre-Approval Information with Payers
Session Chair(s)
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
Director of Regulatory Affairs, Biogen, United States
Industry Perspective
Susan A Cantrell, RPH
Chief Executive Officer, Academy of Managed Care Pharmacy (AMCP), United States
Industry Update
Lucy Rose, MBA
President, Lucy Rose and Associates, United States
Industry Update
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