Bringing the Views of "Payer Regulators" into Product Development to Align Label Outcomes and Safety with Patient Access
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
275
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
Location:
253B
CHAIR
:
Charles A. Stevens, JD,MBA (SCHNON), Vice President and General Manager, PAREXEL Consulting, United States
Chuck is the vice president & general manager of commercialization strategy at PAREXEL, responsible for leading the development of strategic and tactical commercialization and market access solutions designed to support the commercial success of biopharmaceutical products, devices and diagnostics.
SPEAKER
(S):
Tamar R. Thompson, (SPKNON), Vice President, Hillco HEALTH, United States
Brian Carey, JD (SPKNON), Partner, Life Sciences and Health Care, Foley Hoag LLP, United States
Brian Carey’s legal practice focuses on advising a wide range of clients on federal legislative and regulatory issues impacting the life sciences and health care sectors.
Description
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.