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EN ISO 27953-2:2011

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

Publication date:   Jun 18, 2012

General information

60.60 Standard published   Dec 1, 2011

CEN

CEN/TC 251 Health informatics

European Norm

35.240.80   IT applications in health care technology

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Scope

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.

Life cycle

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PUBLISHED
EN ISO 27953-2:2011
60.60 Standard published
Dec 1, 2011