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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 27953:2011

ISO 27953:2011 Health informatics – Individual case safety reports (ICSRs) in pharmacovigilance – Part 2: Human pharmaceutical reporting requirements for ICSR

CDN $435.00

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 Detail Icon

English

Format Secure Icon

Secure PDF

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.

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