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Preparing for CMC Meetings with the FDA
Program Code:
230
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Michael Folkendt has 18+ years of FDA experience and is now the Associate Director for Regulatory Affairs in the Office of New Drug Quality Assessment. In this role, he manages office project managers and develops review policies & procedures. He has a M.S. degree in Chemistry from the UC, Davis.
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PRESENTER
(S):
Jeannie David, FDA, United States
Antoinette Paone, Vertex Pharmaceuticals Incorporated, United States
Ms. Nearing has been in Regulatory Affairs for 22.5 years: currently as a Senior Director in Global Regulatory Affairs for Quintiles, and previously in Regulatory Affairs with the FDA for 12.5 years, and 5 years with Industry at Solvay Pharmaceuticals and Johnson & Johnson Pharmaceuticals.
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Description
Meetings with the FDA are an important part of the drug development process. This session will provide insight on how and when to best meet with the FDA, how to successfully request and plan for a CMC meeting for CDER NDAs ,BLAs, and supplements.
Learning Objectives:
Discuss the differences (both in scope and participants) between CMC-only meetings and other meetings with the FDA
Identify how and when to request a CMC-only meeting
Discuss how to prepare for a CMC meeting with the FDA.