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PMS of diagnostics - WHO · PDF file PMS for prequalified diagnostics - The impact on diagnostics procurement PMS information collected through the performance of the activities described

Jun 13, 2020

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  • WHO PMS for diagnostics | 4 February 20091 |

    Post-market surveillance of diagnostics: The WHO post-market surveillance

    system for diagnostics

    Post-market surveillance of diagnostics:

    The WHO post-market surveillance

    system for diagnostics

    Informal Consultative Meeting for Diagnostic Manufacturer Associations, UN Procurement Agencies and WHO 4 February 2009, WHO HQ, Geneva

    Ms Irena Prat Department of Essential Health Technologies

    Informal Consultative Meeting for Diagnostic Manufacturer Associations, UN Procurement Agencies and WHO 4 February 2009, WHO HQ, Geneva

    Ms Irena Prat Department of Essential Health Technologies

  • WHO PMS for diagnostics | 4 February 20092 |

    Presentation contents Presentation contents

    ○ Post-market surveillance of diagnostics - introduction

    ○ Roles of key players in the WHO PMS system for Dx

    ○ Core activities of the WHO PMS system for Dx

    ○ Implementation of the WHO PMS programme in resource

    limited settings

  • WHO PMS for diagnostics | 4 February 20093 |

    About post-market surveillance for diagnosticsAbout post-market surveillance for diagnostics

    ○ International standards requirements on the PMS system

    establishment by the manufacturer

    ○ PMS provides a continuous feedback on the Dx on the

    market

    ○ PMS helps the manufacturer to maintain a high standard of

    product quality and customer satisfaction

  • WHO PMS for diagnostics | 4 February 20094 |

    PMS for prequalified diagnostics: Why is it needed

    PMS for prequalified diagnostics: Why is it needed

    As a prequalified diagnostic (PQDx) is placed on the market

    it is necessary to make sure that:

    ○ It continues to meet all safety and performance

    requirements and standards that were required for the

    PQ approval

    ○ Any problems with the use of the product are dealt with

    and reported through appropriate channels

    The post-market phase of a Dx is as important as the

    assessment and evaluation performed within PQ

  • WHO PMS for diagnostics | 4 February 20095 |

    PMS for prequalified diagnostics: Why is it needed

    PMS for prequalified diagnostics: Why is it needed

    A PMS programme has been developed by WHO to:

    ○ Ensure the ongoing compliance of PQDx with PQ requirements once placed on the market

    ○ Strengthen National regulatory authorities (NRAs) by providing operational guidance documents and training programs on PMS

  • WHO PMS for diagnostics | 4 February 20096 |

    Roles of key players in the WHO PMS system for PQ Dx

    Roles of key players in the WHO PMS system for PQ Dx

    ○ Manufacturers maintaining high product quality and

    reporting on adverse events

    ○ NRAs and National reference laboratories (NRLs)

    performing PMS activities in the country and providing

    feedback on diagnostics performance in the field

    ○ WHO/EHT/DLT unit ensuring traceability of PQDx and

    providing support to manufacturers, end users and NRAs

    facing problems with PQDx

    ○ End users identifying problems with Dx

  • WHO PMS for diagnostics | 4 February 20097 |

    Core activities of the WHO post-market surveillance system for diagnostics

    Core activities of the WHO post-market surveillance system for diagnostics

    The WHO PMS system for PQDx comprises two main

    components:

    ○ Proactive surveillance activities allowing collection of

    information on quality, safety and performance of the Dx

    after it has been placed on the market

    ○ A reactive vigilance system for the notification and

    evaluation of adverse events involving PQDx

  • WHO PMS for diagnostics | 4 February 20098 |

    Core activities of the WHO post-market surveillance system for diagnostics

    Core activities of the WHO post-market surveillance system for diagnostics

    The WHO PMS system for PQ Dx is implemented through the

    performance of three core activities:

    PMS for PQDx

    Proactive component Reactive component

    (3) The vigilance

    system

    (1) Batch release

    testing (2) Sampling and testing

    of samples from the field

  • WHO PMS for diagnostics | 4 February 20099 |

    Batch release testingBatch release testing

    Reasons for batch release testing:

    ○ Difference in quality between batches of the same diagnostic may occur

    ○ Inappropriate transport and storage conditions (temperature, humidity, exposure to sunlight…) may affect diagnostic's performance

    ○ A high level of reliability can only be guaranteed through testing of each batch procured in a country

  • WHO PMS for diagnostics | 4 February 200910 |

    Batch release testingBatch release testing

    Purpose of batch release testing:

    ○ Ensure that the Dx delivered meet the PQ requirements

    and that the manufacturer's claims on product's

    performance stand up as the Dx is procured to a Member

    State

    ○ Ensure that only batches with satisfactory test results are

    distributed to laboratories all over the country.

  • WHO PMS for diagnostics | 4 February 200911 |

    Batch release testingBatch release testing

    Batch release testing procedure:

    ○ Batch release sampling of each incoming delivery of PQ Dx

    in a Member State for independent laboratory analysis in

    the NRL

    ○ Analysis of compliance with the product's specifications

    using the WHO evaluation panel of well-characterized

    specimens

    ○ Manufacturer's package insert followed

  • WHO PMS for diagnostics | 4 February 200912 |

    Testing of samples from the filedTesting of samples from the filed

    Reasons for sampling and testing of samples form the filed:

    ○ Inappropriate transport (temperature, humidity, exposure to sunlight…) after procurement of the assays to the country may affect the assay's performance when used in the field

    ○ Inappropriate storage conditions after procurement of the assays to the country may affect the assay's performance when used in the field

  • WHO PMS for diagnostics | 4 February 200913 |

    Testing of samples from the filedTesting of samples from the filed

    Purpose of sampling and testing of samples form the filed:

    ○ Get an oversight of the performance of the tests sampled in laboratories at different levels within the country

    ○ Testing of samples from the field in combination with batch release testing guarantees the monitoring of assay quality throughout the distribution chain

  • WHO PMS for diagnostics | 4 February 200914 |

    Testing of samples from the filedTesting of samples from the filed

    Sampling and testing of samples from the field

    procedure:

    ○ Samples of PQ Dx are taken in different laboratories twice

    per year for independent laboratory analysis in the NRL

    ○ Analysis of compliance with the product's specifications

    using the WHO evaluation panel of well-characterized

    specimens

    ○ Manufacturer's package insert followed

  • WHO PMS for diagnostics | 4 February 200915 |

    The vigilance systemThe vigilance system

    WHO has adopted an internationally accepted approach to the vigilance system developed by the GHTF and adapted it for the needs of the WHO PQDx PMS system

    Purpose of the vigilance system for PQDx:

    ○ Ensure traceability of information on PQDx

    ○ Enable coordinated action in countries where PQDx are supplied

  • WHO PMS for diagnostics | 4 February 200916 |

    The vigilance systemThe vigilance system

    The vigilance procedure:

    ○ Vigilance notifications submitted to WHO will be

    evaluated

    ○ Manufacturer's investigation will be monitored

    ○ Information exchange might be undertaken with NRAs

    Reporting forms for manufacturers, end users and NRAs and

    instructions for fulfilment of these forms are being

    developed for vigilance data exchange with WHO

  • WHO PMS for diagnostics | 4 February 200917 |

    The vigilance systemThe vigilance system

    The vigilance system for PQDx will be developed at two

    levels:

    ○ Vigilance data on PQDx will be centrally collected and

    evaluated by WHO (short-term)

    ○ Guidance documents and training programs will help

    countries frame policies on vigilance procedures at

    national level (long-term)

  • WHO PMS for diagnostics | 4 February 200918 |

    PMS for prequalified diagnostics - The impact on diagnostics procurement

    PMS for prequalified diagnostics - The impact on diagnostics procurement

    PMS information collected through the performance of the

    activities described will ensure that only PQDx that

    continue to meet prequalification criteria once put on the

    market will be used in countries

    Unsatisfactory PMS data will be dealt with in cooperation with

    the manufacturer and the NRAs concerned

  • WHO PMS for diagnostics | 4 February 200919 |

    Implementation of the WHO post-market surveillance programme in