DIA 48th Annual Meeting
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The State of Electronic Submissions at CDER, CBER, and CDRH
Track
:
Track 17: Global Regulatory
Program Code:
394
Date:
Wednesday, June 27, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Gary Gensinger, FDA, United States
PRESENTER
(S):
Terrie Reed, FDA, United States Virginia Hussong, FDA, United States Hilmar Hamann, FDA, United States
Michael Fauntleroy, FDA, United States
Description
CDER, CBER, and CDRH are working towards all-electronic environments, in order to streamline and facilitate the review of electronic submissions. This session focuses on Center goals, experiences and practical advice for sponsors and consultants.
Learning Objectives:
Explain CDER's, CBER's, and CDRH's current initiatives and future vision with respect to electronic submissions and implementation of standards
Identify technical challenges associated with maintaining regulatory compliance from FDA's perspective.
Learning Objectives:
Explain CDER's, CBER's, and CDRH's current initiatives and future vision with respect to electronic submissions and implementation of standards
Identify technical challenges associated with maintaining regulatory compliance from FDA's perspective.
This session is a part of:
Handout Online
