DIA 48th Annual Meeting
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Electronic Drug Registration and Listing: FDA and Industry
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
209
Date:
Tuesday, June 26, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Leyla Rahjou-Esfandiary, FDA, United States
PRESENTER
(S):
Soo Jin Park, FDA, United States
Theresa Brunone, GlaxoSmithKline, United States Patricia Cowall-Hanover, Eli Lilly and Company, United States
Description
This session will provide a regulatory overview of drug establishment registration and drug listing requirements, FDA's National Drug Code (NDC) Directory, the Drug Establishments Current Registration Site (DECRS), some recent updates, and also industry's perspective; challenges and benefits.
Learning Objectives:
Identify who must register and list and how
Identify some the recent changes: Describe how to get help on challenging cases
Describe downstream uses of SPL and some of the benefits to going electronic
Learning Objectives:
Identify who must register and list and how
Identify some the recent changes: Describe how to get help on challenging cases
Describe downstream uses of SPL and some of the benefits to going electronic
This session is a part of:
Handout Online
