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ISO/HL7 27953-2:2011

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR
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ISO/HL7 27953-2:2011

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR

ISO/HL7 27953-2:2011

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.

SDO ISO: International Organization for Standardization
Document Number ISO/HL7 27953
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 215
Publish Date Document Id Type View
Not Available ISO/HL7 27953-2:2011 Revision