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Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access
Session Chair(s)
Charles A. Stevens, JD, MBA
Vice President and General Manager
PAREXEL Consulting, United States
This session will discuss how data requirements of payer regulators postapproval can be different than the needs of regulators working on product approval. Developing market facing data during development can impact product label, patient access and overall product success.
Learning Objective : Discuss the growing importance payer regulators have on the product development process, clinical trial design and product label; Describe when and how payer regulators would like to become involved in the product development process; Explain the importance payers can have on product success.
Speaker(s)
Panelist
Tamar R. Thompson
Hillco HEALTH, United States
Vice President
Panelist
Brian Carey , JD
Foley Hoag LLP, United States
Partner, Life Sciences and Health Care
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