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Which Regulatory Project Management Staff at FDA Should You Engage With? When and How?
Session Chair(s)
Wayne Amchin
Senior Consumer Safety Officer, ORO, DRCHEN, 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)
Panelist
Renmeet Grewal, PharmD, MS
FDA, United States
Division Director, Office of Regulatory Operations (DRO-II), OND, CDER
Panelist
Sean Bradley
US Food and Drug Administration, United States
Associate Director of Review Management
Panelist
Hamet M. Toure, PharmD, MPH
FDA, United States
Program Management, OPRO, OPQ, CDER
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