Norm

NEN-EN-ISO 27953-1:2010 2e Ontw. en

Medische informatica - Geneesmiddelenbewaking - Individuele meldingen van bijwerkingen - Deel 1: Het kader voor het melden van bijwerkingen

  • Deze norm is ingetrokken sinds 14-12-2011

101,92

Over deze norm

Status Ingetrokken
Aantal pagina's 479
Commissie Informatievoorziening in de zorg
Gepubliceerd op 01-07-2010
Taal Engels
Part 1 of this standard seeks to establish 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 may occur upon the administration or use of one or more products. The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases described in the storyboard section of this ballot. It should be noted that Part 1 will be harmonized over time with other HL7 public health and patient safety reporting standards to help insure messaging constructs and vocabulary are harmonized in the HL7 Public Heath and Regulatory Reporting domains. Furthermore, Part 1 of this standard does not govern or dictate reporting requirements for any product. However, the regulatory use cases (storyboards) described in this standard were derived from a variety of data sources including draft and final versions of internationally harmonized guidelines from the International Conference on Harmonisation, the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL 42, and the Global Harmonization Task Force (GHTF) Study Group 2 N87 guideline. The storyboards are for demonstration purposes only and help demonstrate the standard's scalability and interoperability across multiple stakeholders and product types. Future releases of this standard may be developed to include conformance profiles (templates) and vocabulary for all or a limited subset of the use cases.

Details

ICS-code 35.240.80
Nederlandse titel Medische informatica - Geneesmiddelenbewaking - Individuele meldingen van bijwerkingen - Deel 1: Het kader voor het melden van bijwerkingen
Engelse titel Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: The framework for adverse event reporting
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