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ISO/HL7 27953-2:2011

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO/HL7 27953-2:2011
Document Year: 2011
Edition: 1
  • ICS:
  • 35.240.80 IT applications in health care technology

Life Cycle

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ISO/HL7 27953-2:2011
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