Home

ISO/HL7 27953-2:2011
Subscribe to updates

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

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.

 

Related standards

Format
  • PDF

    This format preserves the paper layout, and is watermarked

  • EPUB

    This format allows documents to be read on tablets and smartphones

  • COLOUR PDF

    Enhanced user-friendly colour PDF format

  • PAPER

    Normally A4 size documents. Shipping costs apply

Language
HTML
HTML on CD

Swiss francs CHF 198

Add to basket

Contact customer services

Send your enquiry by email
or call us on +41 22 749 08 88
09:00 – 12:30, 14:00 – 17:00 (UTC+1).