SN 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/DIS 27953-2:2011)
Hardcopy
English
01-06-2012
Important note : Users cannot be edited or removed once added to your Multi user PDF.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 |
INB/NK 165
|
| DocumentType |
Standard
|
| Pages |
0
|
| ProductNote |
This standard is identical to ISO 27953-2:2011
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 27953-2:2011 | Identical |
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