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Cross-regional alignment, IDMP, ICSR standards, and global PV reporting.
12 terms
Identification of Medicinal Products; ISO standards (IDMP) for unique identification of substances, products, and packages. Supports global exchange and regulatory reporting.
Standards for electronic exchange of ICSRs (e.g., ICH E2B(R3), HL7); ensure interoperability between MAHs and authorities.
MedDRA is released twice yearly (March, September). MAHs must plan upgrades and map legacy data; coding consistency affects signal detection.
WHO-supported web-based system for managing and reporting ICSRs; used by many national centres and PvPI.
Agreement between partners (e.g., co-marketing) on exchange of safety data and reporting responsibilities.
Therapeutically active ingredient; identified in E2B and labeling. IDMP includes substance identifiers.
Process of upgrading database and reports to new MedDRA version; impact on coding and analyses.
Mapping historical data to new standard (e.g., MedDRA, E2B(R3)); ensures consistency.
Substance, Product, Organisation, Referential (EU); master data for IDMP and regulatory submissions.
Extended EudraVigilance Medicinal Product Dictionary; product data for EV (being replaced by SPOR).
Identifier that can be used to link same case across submissions (e.g., to avoid duplicate at authority).
Exchange of safety data between partners (e.g., licensees) per SDEA.