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Electronic Drug Registration and Listing: FDA and Industry
Program Code:
209
Date:
Tuesday, June 26, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Earned her PharmD from Tehran University in Iran in 1997. She's been working in private sector and government in the US since then. She joined the Drug Registration and Listing Team in 2008 and has been working on the implementation of the electronic system for registration and listing ever since.
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PRESENTER
(S):
Soo Jin Park, FDA, United States
Terry is the Chair of the HL7 Structured Product Labeling Workgroup, a cross-industry workgroup involved in the implementation of SPL for FDA and beyond. Terry works at GlaxoSmithKline, where she manages a Labeling Coordination group as part of the Global Labelling function at GSK.
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Pat Cowall-Hanover is a Regulatory Consultant at Eli Lilly and Company, where she is responsible for coordinating SPL, electronic drug listing, labeling for drug/device combination products. She is also co-chair of the SPL ER/DL working group.
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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