DIA 48th Annual Meeting
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Pursuing Standards to Enhance eCTD Deliverables: PhRMA Electronic Regulatory Submissions (ERS) Group Annual Update
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
338
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
John Kiser, Abbott Laboratories, United States
PRESENTER
(S):
Cynthia Piccirrillo, Bristol-Myers Squibb
Michelle Charles, Merck & Co., Inc., United States
Joseph Cipollina, Bristol-Myers Squibb Company, United States
Description
The PhRMA Electronic Regulatory Submissions group presents their annual progress report on the hottest key subteams involved in the pursuit of standards to facilitate efficient and effective electronic submissions.
Learning Objectives:
Discuss progress made since 2011 on key hot-topic industry/agency initiatives
Identify anticipated benefits and business impact of the next major version of eCTD and progress towards efficient submission creation (bookmarking and hypertext linking).
Learning Objectives:
Discuss progress made since 2011 on key hot-topic industry/agency initiatives
Identify anticipated benefits and business impact of the next major version of eCTD and progress towards efficient submission creation (bookmarking and hypertext linking).
This session is a part of:
Handout Online
