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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


Priority Review Vouchers: Here to Stay and Worth the Effort?

    Session Chair(s)
      Kim  Quaintance-Lunn

      Kim Quaintance-Lunn

      • Vice President, Regulatory Policy, NA
      • Bayer, 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

      Value

      Andrew Robertson, JD, PhD

      • Head, Global Regulatory Science and Policy, NA
      • Sanofi, United States
      John  Jenkins, DrMed, MD

      Strategy

      John Jenkins, DrMed, MD

      • Principal, Drug and Biological Products
      • Greenleaf Health, United States
      Larry  Bauer, MA, RN

      Process

      Larry Bauer, MA, RN

      • Regulatory Scientist, Rare Diseases Program, Office of New Drugs, CDER
      • FDA, United States