- June 11, 2021
1:00 PM - 2:30 PM ET
FDA will present updates on the Identification of Medicinal Products (IDMP) standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form and pharmaceutical identification (PhPID).
- Overview of FDA’s Approach to IDMP and its global implementation
- Collaboration with European Union (EU) European Medicines Agency on the implementation of the Global Substance Registration System (GSRS) and EU Substance Registration System (SRS)
- Outcome of an international pilot evaluation to demonstrate the use of dose form characteristics as input in the generation of PhPID
- GSRS a useful tool for substance registration in small businesses
Pharmaceutical and regulatory authority professionals working in areas such as pharmacovigilance, product labeling, electronic submissions, and data standards.
Ron Fitzmartin, PhD, MBA
Sr. Informatics Advisor
Office of the Director | Center for Biologics Evaluation and Research (CBER)
Project Management Officer
Office of Strategic Programs | Center for Drug Evaluation and Research (CDER)
Office of Health Informatics (OHI) | Office of Chief Scientist (OCS)
Lawrence Callahan, PhD
OHI | OCS
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