EN ISO 27953-2:2011
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)
01-12-2011
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.
| Committee |
CEN/TC 251
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| ISO/HL7 27953-2:2011 | Identical |
| NBN EN ISO 27953-2 : 2012 | Identical |
| NEN EN ISO 27953-2 : 2011 | Identical |
| SN EN ISO 27953-2:2012 | Identical |
| I.S. EN ISO 27953-2:2011 | Identical |
| DIN EN ISO 27953-2:2012-09 | Identical |
| NS EN ISO 27953-2 : 2011 | Identical |
| UNI EN ISO 27953-2 : 2012 | Identical |
| NF EN ISO 27953-2 : 2013 | Identical |
| PN EN ISO 27953-2 : 2012 | Identical |
| UNE-EN ISO 27953-2:2011 | Identical |
| BS EN ISO 27953-2:2011 | Identical |
| PNE-prEN ISO 27953-2 | Identical |
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