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DIA 2018 Global Annual Meeting

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


Which Regulatory Project Management Staff at FDA Should You Engage With? When and How?

    Session Chair(s)
      Wayne  Amchin, MA, MPA, RAC

      Wayne Amchin, MA, MPA, RAC

      • Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER
      • FDA, United States
    This forum will include multiple regulatory project management staff from the FDA who will give a brief presentation of their roles and responsibilities and describe what their role is during the drug development process. Each project management group has a very unique role during the drug development process and this will be presented during the forum. During the panel discussion each group will explain how they communicate and collaborate amongst each other and keep each other informed. After the presentations, a representative from each group will be a part of the panel discussion to answer questions from the audience members.
    Learning Objective : Describe the different offices throughout CDER which have their own regulatory project management staff; Explain the appropriate regulatory project manager to contact about for specific issues relevant to your product application - IND, NDA, BLA, combination product; Design best practices for managing interactions with FDA.
    Speaker(s)
      Renmeet  Grewal, PharmD, MS, RAC

      Panelist

      Renmeet Grewal, PharmD, MS, RAC

      • Chief, Project Manager, Office of Clinical Pharmacology, OTS, CDER
      • FDA, United States
      Sean K Bradley, PharmD, RPh

      Panelist

      Sean K Bradley, PharmD, RPh

      • Chief Project Manager, Safety Regulatory Management Staff, OSE, CDER
      • FDA, United States
      Hamet M. Toure, PharmD, MPH

      Panelist

      Hamet M. Toure, PharmD, MPH

      • Program Management, OPRO, OPQ, CDER
      • FDA, United States