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Global IDMP Implementation - Getting Closer to the Goal

Автор: U.S. Food and Drug Administration

Загружено: 2024-10-21

Просмотров: 1012

Описание: This webinar presented an overview of the end-to-end testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The session detailed the model's readiness for deployment, including its software functionality, interoperability, processes, and business rules.

Timestamps

00:56 – Global IDMP Implementation: Getting Closer to the Goal

12:20 – GIDWG Global IDMP Identifiers

47:37 – Global IDMP Implementation: Readiness

01:05:57 – Q&A Session

Speakers | Panelists:

Ron Fitzmartin, PhD, MBA
Sr. Advisor
Data Standards Branch
Office of Regulatory Operations
Center for Biologics Evaluation and Research

Ta-Jen Chen
Project Management Officer
Office of Strategic Programs
Center for Drug Evaluation and Research

Olof Lagerlund, PhD
Substance Expert
Uppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring

Learn more at: https://www.fda.gov/drugs/news-events...

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accoun...
SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...  
SBIA LinkedIn -   / cder-small-business-and-industry-assistance  
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter -   / fda_drug_info  
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367

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