Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -- Part 2: Human pharmaceutical reporting requirements for ICSR
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This standard was last reviewed and confirmed* in 2016.
ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.
Document published on: 2011-12 Edition: 1 (Monolingual) ICS: 35.240.80 Status: Published Stage: 90.93 (2016-12-09) TC/SC: ISO/TC 215 Number of Pages: 585
This standard has not been revised
No corrigenda or amendments available