HEALTH INFORMATICS - INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IN PHARMACOVIGILANCE - PART 2: HUMAN PHARMACEUTICAL REPORTING REQUIREMENTS FOR ICSR (ISO/DIS 27953-2:2011)

Available format(s)

Hardcopy

Language(s)

English

Published date

01-06-2012

Publisher

Swiss Standards

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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SN EN ISO 27953-2:2012

HEALTH INFORMATICS - INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IN PHARMACOVIGILANCE - PART 2: HUMAN PHARMACEUTICAL REPORTING REQUIREMENTS FOR ICSR (ISO/DIS 27953-2:2011)

Abstract

General Product Information

International Equivalents

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