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  5. FDA’s Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs) uniquely define substances in FDA-regulated products - 06/08/2023
  1. FDA Grand Rounds

Webcast | Virtual

Event Title
FDA’s Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs) uniquely define substances in FDA-regulated products
June 8, 2023

Date:
June 8, 2023
Time:
12:00 PM - 1:00 PM ET
Image
Grand Rounds

About the Speaker:

Marlene Kim, PhD, Health Informatics Staff (HIS)
Office of Data, Analytics, & Research (ODAR)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC)
U.S. Food and Drug Administration (FDA)

Dr. Marlene Kim is a chemist specializing in cheminformatics and computational toxicology. She received her PhD in Computational and Integrative Biology from Rutgers University-Camden, New Jersey. She was also a chemistry and general science teacher (including earth and space science and physical science).  Previously, at FDA’s Center for Drug Evaluation and Research (CDER), Dr. Kim assessed (quantitative) structure-activity relationship predictions and read-across reports submitted by applicants.  Today she is a registrar for FDA’s Global Substance Registration System (GSRS), which defines ingredient substances such as drugs, botanicals, biologics, and cosmetics of FDA-regulated products.

About the Presentation:

FDA’s Global Substance Registration System (GSRS) makes it possible for substances to be defined by standardized, scientific descriptions that are now used by our partners worldwide. All substances are assigned Unique Ingredient Identifiers (UNIIs). This presentation will highlight UNIIs, the various types of substances captured, and briefly highlight types of data linked to records.

Learning Objectives:

  1. Describe how GSRS accurately registers and manages records
  2. Discuss how a substance search is done and the record interpreted

Webcast Recording

https://fda.zoomgov.com/rec/share/c7FRN06akCSKetzt51xMQr4HknVoYakFi5n-As1-l7ObsCPkTAEiH251qN98WDKk.ntTdN2z1jwzJHiCt

Event Materials

Activity Announcement for FDA Grand Rounds – June 8, 2023

 

For technical assistance please contact: Rokhsareh.Shahidzadeh@fda.hhs.gov

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