Norm

NEN-EN-ISO 27953-2:2010 2e Ontw. en

Medische informatica - Geneesmiddelenbewaking - Individuele meldingen van bijwerkingen - Deel 2: Eisen voor individuele meldingen van bijwerkingen van geneesmiddelen bestemd voor mensen

  • Deze norm is ingetrokken sinds 14-12-2011

101,92

Over deze norm

Status Ingetrokken
Aantal pagina's 463
Commissie Informatievoorziening in de zorg
Gepubliceerd op 01-07-2010
Taal Engels
This standard, which contains material drawn from ISO/HL7 27953-1 seeks to create a standardized 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. The standard provides a structure where reports can be exchanged in a clear and unambiguous manner such that the nature of the case, the circumstances in which it arose, and particularly the identity of the medicinal product(s) in question, can be communicated with certainty. Requirements for this use case were initially based upon ICH and conformance for Part 2 includes parallel adoption of ISO vocabulary work items: Data Elements and Structures for the Exchange of Regulated Product Information for Drug Dictionaries (See prEN ISO 11615, 11616, 11238, 11239, and 11240) and Structures and Controlled Vocabularies for Laboratory Test Units for the Reporting of Laboratory Results (See prEN ISO 11595).

Details

ICS-code 35.240.80
Nederlandse titel Medische informatica - Geneesmiddelenbewaking - Individuele meldingen van bijwerkingen - Deel 2: Eisen voor individuele meldingen van bijwerkingen van geneesmiddelen bestemd voor mensen
Engelse titel Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR
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