PN EN ISO 27953-2 : 2012
Current
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IN PHARMACOVIGILANCE - PART 2: HUMAN PHARMACEUTICAL REPORTING REQUIREMENTS FOR ICSR (ISO 27953-2:2011)
Published date
01-12-2013
Publisher
Provides a framework for international regulatory reporting and information sharing by providing a common set of data elements and messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that may occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.
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