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SSH 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)

Mar 23, 2012

General information

60.60     Mar 23, 2012

DPS

DPS/KT 224

European Norm

35.240.80  

English  

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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
SSH EN ISO 27953-2:2011
60.60 Standard published
Mar 23, 2012

Related project

Adopted from EN ISO 27953-2:2011