DIA 48th Annual Meeting
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Future Directions for eCTD Module 1
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
313
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Gary Gensinger, FDA, United States
PRESENTER
(S):
Constance Robinson, FDA, United States Mark Gray, FDA, United States Marci Kiester, FDA, United States
Description
Discussion will include key changes to Module 1, including incorporating the eCTD standard into the review of promotional materials. Also included will be reviewer concerns, file types accepted and presentation of specific examples.
Learning Objectives:
Identify key changes to eCTD Module 1
Describe the process for electronic submission (eCTD) of promotional materials to CDER DDMAC, including understanding how to use the updated 1.15 heading in Module 1.
Learning Objectives:
Identify key changes to eCTD Module 1
Describe the process for electronic submission (eCTD) of promotional materials to CDER DDMAC, including understanding how to use the updated 1.15 heading in Module 1.
This session is a part of:
Handout Online
