×
Back to Agenda
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)
Andrew Robertson, JD, PHD
Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
John Jenkins
Principal, JKJ Advisors, LLC, United States
Larry Bauer, MA, RN
Senior Regulatory Drug Expert, Hyman, Phelps & McNamara, P.C., United States
Have an account?