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SRPS EN ISO 27953-2:2014

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

Oct 31, 2014

General information

60.60     Oct 31, 2014

ISS

I215

European Norm

35.240.80  

English  

ISO standard je na CD.

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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.

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PUBLISHED
SRPS EN ISO 27953-2:2014
60.60 Standard published
Oct 31, 2014

Related project

Adopted from EN ISO 27953-2:2011

Adopted from ISO/HL7 27953-2:2011 IDENTICAL