ISO/HL7 27953-2:2011

Published (Edition 1, 2011)

This standard was last reviewed and confirmed in 2022. Therefore this version remains current.

ISO/HL7 27953-2:2011

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Abstract

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.

General information

Status
: Published

Publication date
: 2011-12

Corrected version (en)
: 2012-10

Stage
: International Standard confirmed [90.93]
Edition
: 1

Number of pages
: 585
Technical Committee :
ISO/TC 215

ICS :
35.240.80
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