Module 12 2019

FDA Involvement with Data Standards Development Organizations (SDOs)

• International Organization for Standardization (ISO) ✓ Identification of Medicinal Products (IDMP) ✓ Individual Case Safety Reports (ICSR)

Health Level Seven (HL7) ✓ Structured Product Labeling (HL7 SPL) ✓ Common Product Model (HL7 CPM) CDISC ✓ Study Data Tabulation Model (SDTM) ✓ Analysis Data Model (ADaM)

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• International Conference on Harmonisation (ICH) ✓ MedDRA

The Organisation for Professionals in Regulatory Affairs