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NEN EN ISO 27953-1 : 2011

Current

Current

The latest, up-to-date edition.

HEALTH INFORMATICS - INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IN PHARMACOVIGILANCE - PART 1: FRAMEWORK FOR ADVERSE EVENT REPORTING

Published date

12-01-2013

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Defines an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that can occur upon the administration or use of one or more products.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

Standards Relationship
ISO/HL7 27953-1:2011 Identical
EN ISO 27953-1:2011 Identical

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