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    Good Clinical Practice Directive

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    Deen
    The Good Clinical Practice Directive lays down principles and guidelines for conducting clinical trials of medicinal products for human use in the EU. It addresses good clinical practice for trial design, conduct, recording and reporting. It also addresses requirements for authorization of manufacturing or importing investigational medicinal products. The directive covers topics like the investigator's brochure, trial master files, inspectors and inspection procedures.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Good Clinical Practice Directive

    Uploaded by

    Deen
    38 views5 pages
    The Good Clinical Practice Directive lays down principles and guidelines for conducting clinical trials of medicinal products for human use in the EU. It addresses good clinical practice for trial design, conduct, recording and reporting. It also addresses requirements for authorization of manufacturing or importing investigational medicinal products. The directive covers topics like the investigator's brochure, trial master files, inspectors and inspection procedures.

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    Good Clinical Practice Directive Europe Union

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    The Good Clinical Practice Directive lays down principles and guidelines for conducting clinical trials of medicinal products for human use in the EU. It addresses good clinical practice for trial design, conduct, recording and reporting. It also addresses requirements for authorization of manufacturing or importing investigational medicinal products. The directive covers topics like the investigator's brochure, trial master files, inspectors and inspection procedures.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    38 views5 pages

    Good Clinical Practice Directive

    Uploaded by

    Deen
    The Good Clinical Practice Directive lays down principles and guidelines for conducting clinical trials of medicinal products for human use in the EU. It addresses good clinical practice for trial design, conduct, recording and reporting. It also addresses requirements for authorization of manufacturing or importing investigational medicinal products. The directive covers topics like the investigator's brochure, trial master files, inspectors and inspection procedures.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 5

    Good Clinical Practice Directive

    From Wikipedia, the free encyclopedia


      (Redirected from Directive 2005/28/EC)

    Jump to navigationJump to search


    The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
    European Parliament and of the Council) lays down principles and detailed guidelines
    for good clinical practice as regards conducting clinical trials of medicinal products for
    human use, as well as the requirements for authorisation of the manufacturing or
    importation of such products.
    The directive deals with the following items:

     Good clinical practice for the design, conduct, recording and reporting of clinical
    trials:
    o Good Clinical Practice (GCP)
    o The Ethics Committee
    o The sponsors
     Investigator's Brochure
     Manufacturing or import authorisation
    o Exemption for Hospital & Health Centres and Reconstitution
    o Conditions of Holding a Manufacturing Licence
     The Trial master file and archiving
    o Format of Trial Master File
    o Retention of Essential and Medical Records
     Inspectors
     Inspection procedures
     Final provisions

    References[edit]
     Text of the directive: Commission Directive 2005/28/EC of 8 April 2005 laying
    down principles and detailed guidelines for good clinical practice as regards
    investigational medicinal products for human use, as well as the requirements for
    authorisation of the manufacturing or importation of such products
     National implementing measures of the EU-countries

    See also[edit]
     EudraLex
     Directive 65/65/EEC1
     Directive 75/318/EEC
     Directive 75/319/EEC
     Directive 93/41/EEC
     Directive 2001/20/EC
     Directive 2001/83/EC
     Regulation of therapeutic goods
     European Medicines Agency
     Common Technical Document
    Good Clinical Practice Directive
    From Wikipedia, the free encyclopedia
      (Redirected from Directive 2005/28/EC)

    Jump to navigationJump to search


    The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
    European Parliament and of the Council) lays down principles and detailed guidelines
    for good clinical practice as regards conducting clinical trials of medicinal products for
    human use, as well as the requirements for authorisation of the manufacturing or
    importation of such products.
    The directive deals with the following items:

     Good clinical practice for the design, conduct, recording and reporting of clinical
    trials:
    o Good Clinical Practice (GCP)
    o The Ethics Committee
    o The sponsors
     Investigator's Brochure
     Manufacturing or import authorisation
    o Exemption for Hospital & Health Centres and Reconstitution
    o Conditions of Holding a Manufacturing Licence
     The Trial master file and archiving
    o Format of Trial Master File
    o Retention of Essential and Medical Records
     Inspectors
     Inspection procedures
     Final provisions

    References[edit]
     Text of the directive: Commission Directive 2005/28/EC of 8 April 2005 laying
    down principles and detailed guidelines for good clinical practice as regards
    investigational medicinal products for human use, as well as the requirements for
    authorisation of the manufacturing or importation of such products
     National implementing measures of the EU-countries

    See also[edit]
     EudraLex
     Directive 65/65/EEC1
     Directive 75/318/EEC
     Directive 75/319/EEC
     Directive 93/41/EEC
     Directive 2001/20/EC
     Directive 2001/83/EC
     Regulation of therapeutic goods
     European Medicines Agency
     Common Technical Document
    Good Clinical Practice Directive
    From Wikipedia, the free encyclopedia
      (Redirected from Directive 2005/28/EC)

    Jump to navigationJump to search


    The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
    European Parliament and of the Council) lays down principles and detailed guidelines
    for good clinical practice as regards conducting clinical trials of medicinal products for
    human use, as well as the requirements for authorisation of the manufacturing or
    importation of such products.
    The directive deals with the following items:

     Good clinical practice for the design, conduct, recording and reporting of clinical
    trials:
    o Good Clinical Practice (GCP)
    o The Ethics Committee
    o The sponsors
     Investigator's Brochure
     Manufacturing or import authorisation
    o Exemption for Hospital & Health Centres and Reconstitution
    o Conditions of Holding a Manufacturing Licence
     The Trial master file and archiving
    o Format of Trial Master File
    o Retention of Essential and Medical Records
     Inspectors
     Inspection procedures
     Final provisions

    References[edit]
     Text of the directive: Commission Directive 2005/28/EC of 8 April 2005 laying
    down principles and detailed guidelines for good clinical practice as regards
    investigational medicinal products for human use, as well as the requirements for
    authorisation of the manufacturing or importation of such products
     National implementing measures of the EU-countries

    See also[edit]
     EudraLex
     Directive 65/65/EEC1
     Directive 75/318/EEC
     Directive 75/319/EEC
     Directive 93/41/EEC
     Directive 2001/20/EC
     Directive 2001/83/EC
     Regulation of therapeutic goods
     European Medicines Agency
     Common Technical Document
    Good Clinical Practice Directive
    From Wikipedia, the free encyclopedia
      (Redirected from Directive 2005/28/EC)

    Jump to navigationJump to search


    The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the
    European Parliament and of the Council) lays down principles and detailed guidelines
    for good clinical practice as regards conducting clinical trials of medicinal products for
    human use, as well as the requirements for authorisation of the manufacturing or
    importation of such products.
    The directive deals with the following items:

     Good clinical practice for the design, conduct, recording and reporting of clinical
    trials:
    o Good Clinical Practice (GCP)
    o The Ethics Committee
    o The sponsors
     Investigator's Brochure
     Manufacturing or import authorisation
    o Exemption for Hospital & Health Centres and Reconstitution
    o Conditions of Holding a Manufacturing Licence
     The Trial master file and archiving
    o Format of Trial Master File
    o Retention of Essential and Medical Records
     Inspectors
     Inspection procedures
     Final provisions

    References[edit]
     Text of the directive: Commission Directive 2005/28/EC of 8 April 2005 laying
    down principles and detailed guidelines for good clinical practice as regards
    investigational medicinal products for human use, as well as the requirements for
    authorisation of the manufacturing or importation of such products
     National implementing measures of the EU-countries

    See also[edit]
     EudraLex
     Directive 65/65/EEC1
     Directive 75/318/EEC
     Directive 75/319/EEC
     Directive 93/41/EEC
     Directive 2001/20/EC
     Directive 2001/83/EC
     Regulation of therapeutic goods
     European Medicines Agency
     Common Technical Document

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