DIA 48th Annual Meeting
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Preparing for CMC Meetings with the FDA
Track
:
Track 12: Pharmaceutical Quality
Program Code:
230
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Michael Folkendt, FDA, United States
PRESENTER
(S):
Jeannie David, FDA, United States
Antoinette Paone, Vertex Pharmaceuticals Incorporated, United States
Toni-Marie Nearing, Quintiles, United States
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.
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.
This session is a part of:
Handout Online
