PN EN ISO 27953-2 : 2012
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)
12-01-2013
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.
| Committee |
TC 302
|
| DocumentType |
Standard
|
| PublisherName |
Polish Committee for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| ISO/HL7 27953-2:2011 | Identical |
| EN ISO 27953-2:2011 | Identical |
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