Module 12 Presentations

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