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Priority Review Vouchers: Here to Stay and Worth the Effort?
Session Chair(s)
Kim Quaintance-Lunn
Vice President, Head of Regulatory Science and Execution
Alexion, United States
Priority review vouchers (PRV) have been around since 2007, and the opportunities to earn one have expanded. This session will discuss the value of a PRV, FDA process for awarding them, and things to consider when developing a regulatory strategy.
Learning Objective : Assess the value of a priority review voucher; Evaluate whether a priority review voucher should be incorporated into your development program; Discuss a plan for FDA evaluation of your priority review voucher request.
Speaker(s)
Value
Andrew Robertson, JD, PHD
Takeda Pharmaceuticals, United States
Vice President, Head of Global Regulatory Policy and Innovation
Strategy
John Jenkins
JKJ Advisors, LLC, United States
Principal
Process
Larry Bauer, MA, RN
Hyman, Phelps & McNamara, P.C., United States
Senior Regulatory Drug Expert