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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)
Renmeet Grewal, PHARMD, MS
Division Director, Office of Regulatory Operations (DRO-II), OND, CDER, FDA, United States
Sean Bradley
Associate Director of Review Management, FDA, United States
Hamet M. Toure, PHARMD, MPH
Program Management, OPRO, OPQ, CDER , FDA, United States
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