Informatika e shëndetit - Raportet të sigurisë të rasteve individuale (ICSRs) në farmakovigjilencë - Pjesa 2: Kërkesat e raportimit farmaceutik për njerëzit për ICSR (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)
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.
Life cycle
NOW
PUBLISHED SSH EN ISO 27953-2:2011 60.60
Standard published 23 mar 2012
English