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  • ISO/HL7 27953-2:2011

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  21-11-2011

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    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 Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 27953-2. (11/2011) Available in CD-ROM format (contains program files). (12/2013)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 11240:2013-03 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
    PD CEN ISO/TS 16791:2015 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
    I.S. EN ISO 11238:2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
    S.R. CEN ISO/TS 19256:2017 HEALTH INFORMATICS - REQUIREMENTS FOR MEDICINAL PRODUCT DICTIONARY SYSTEMS FOR HEALTH CARE (ISO/TS 19256:2016)
    S.R. CEN ISO/TS 16791:2015 HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS (ISO/TS 16791:2014)
    BS PD ISO/TS 16791 : 2014 HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS
    PD CEN ISO/TS 20443:2018 Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
    CEN ISO/TS 20443:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)
    UNE-EN ISO 11238:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
    UNE-EN ISO 11615:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)
    UNI EN ISO 11238 : 2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES
    I.S. EN ISO 11616:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017)
    CEN ISO/TS 20451:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)
    ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
    S.R. CEN ISO/TS 20451:2018 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11616 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO/TS 20451:2017)
    UNE-EN ISO 11240:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
    ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
    PD CEN ISO/TS 19256:2017 Health informatics. Requirements for medicinal product dictionary systems for health care
    ISO/TS 20451:2017 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
    EN ISO 11238:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
    BS EN ISO 11238:2012 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances
    EN ISO 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
    CEN ISO/TS 16791:2015 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
    BS EN ISO 11240:2012 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of units of measurement
    16/30344636 DC : 0 BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION
    BS EN ISO 11616:2017 Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    EN ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
    ISO/TS 19256:2016 Health informatics Requirements for medicinal product dictionary systems for health care
    EN ISO 11240:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
    S.R. CEN ISO/TS 20443:2018 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11615 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO/TS 20443:2017)
    BS EN ISO 11615:2017 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information
    ISO 11238:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
    DIN EN ISO 11238:2013-03 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
    I.S. EN ISO 11615:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017)
    UNI EN ISO 11240 : 2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT
    ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    I.S. EN ISO 11240:2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT (ISO 11240:2012)
    ISO/TS 20443:2017 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
    CEN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)
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