PMS of diagnostics - WHO · PMS for prequalified diagnostics - The impact on diagnostics...
Transcript of PMS of diagnostics - WHO · PMS for prequalified diagnostics - The impact on diagnostics...
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 WHO4 February 2009, WHO HQ, Geneva
Ms Irena PratDepartment of Essential Health Technologies
Informal Consultative Meeting for Diagnostic Manufacturer Associations, UN Procurement Agencies and WHO4 February 2009, WHO HQ, Geneva
Ms Irena PratDepartment 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
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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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)
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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
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Implementation of the WHO post-market surveillance programme in resource limited settings
Implementation of the WHO post-market surveillance programme in resource limited settings
Main constraints:
○ Lack of feedback on Dx performance in the field
○ Lack of regulatory framework for performing PMS activities
○ Regulatory capacities limitations
○ Poor manufacturers and end users reporting habits
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Implementation of the WHO post-market surveillance programme in resource limited settings
Implementation of the WHO post-market surveillance programme in resource limited settings
WHO's response to countries needs:
○ Guidance documents giving recommendations on how to
set up and implement a PMS system
○ Training programs to accelerate the implementation
○ PMS Pilot project to gain experience from the field
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Implementation of the WHO post-market surveillance programme in resource limited settings
Implementation of the WHO post-market surveillance programme in resource limited settings
The PMS system will be first launched as pilot project in 5
countries
Feedback information on how the PMS system stands up
when implemented in pilot countries
Experience gained from the pilot project will be used as basis
for possible improvement of the PMS system launched in
pilot countries
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Thank you