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

Standard No.

EN ISO 27953-2:2011

Release Date

2011

Published By

European Committee for Standardization (CEN)

Status

Withdraw 2012-06

Latest

EN ISO 27953-2:2011

Scope

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.

EN ISO 27953-2:2011 history

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