ISO 27953:2011
ISO 27953:2011 Health informatics – Individual case safety reports (ICSRs) in pharmacovigilance – Part 2: Human pharmaceutical reporting requirements for ICSR
CDN $442.00
Description
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.
Edition
1
Published Date
2011-11-21
Status
PUBLISHED
Pages
Not found
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 80000:2019 Quantities and units – Part 11: Characteristic numbers
CDN $352.00 Add to cart -
ISO 5078:2025 Management of terminology resources – Terminology extraction
CDN $263.00 Add to cart -
ISO 22553:2019 Paints and varnishes – Electro-deposition coatings – Part 1: Vocabulary
CDN $86.00 Add to cart -
ISO 4006:1991 Measurement of fluid flow in closed conduits – Vocabulary and symbols
CDN $397.00 Add to cart
