DS/EN ISO/HL7 27953-2:2012
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR

Standard No.

DS/EN ISO/HL7 27953-2:2012

Release Date

2012

Published By

Danish Standards Foundation

Latest

DS/EN ISO/HL7 27953-2:2012

Scope

1.1 ISO 27593-2: International Regulatory Reporting for Human PharmaceuticalsThis part of ISO 27593, which contains material drawn from ISO 27593-1, seeks to create astandardized 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.This International Standard provides a structure where reports can be exchanged in a clear and unambiguou

DS/EN ISO/HL7 27953-2:2012 history

• 2012 DS/EN ISO/HL7 27953-2:2012 Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR