TOPICS - 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
AUDIENCE Pharmaceutical and regulatory authority professionals working in areas such as pharmacovigilance, product labeling, electronic submissions, and data standards. | | 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). | |
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