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News and Events

12th face to face meeting of GDWG in Brussels, 21 January 2020

Key points discussed

  • Expanded eligibility criteria for WHO prequalification of IVDs;
  • Progress on pilot of WHO collaborative registration procedure (CRP) for IVDs;
  • GDWG publication on roles and responsibilities for different types of IVD assessments;
  • Collecting data for post-market surveillance.

Action points agreed

  1. Refinement of IVD assessment publication.
  2. Separate publication for end-user verification studies
  3. Development of PMS policy brief for QC laboratories/reference laboratories.

 

10th face-to-face meeting of GDWG in Abuja, 9 December 2018

Key points discussed

  • Expanding the eligibility criteria for WHO prequalification of IVDs, and expanding the WHO collaborative registration procedure (CRP) to IVDs
  • Presentation on a business case for development of end-user quality control material for post-market surveillance of IVDs
  • Launch of the GDWG website  

Action points agreed

  1. Support verification studies for end-users thus moving away from in-country evaluations that duplicate work performed within the regulatory assessment process or performance evaluations for in-country uptake decisions.
  2. Expand post-market surveillance of IVDs , firstly through development of a position paper for how IVD end-users can collect data for post-market surveillance.
  3. Support development of a WHO policy brief on post-market surveillance for analyser-based IVDs, including acceptable failure rates.
  4. Develop a standardised format for certificate of analysis specific for IVDs
ASLM2018 conference - December 2018

ASLM2018 is the fourth biennial international conference of the African Society for Laboratory Medicine (ASLM).

This years theme is "Preventing and controlling the next pandemic: the role of the laboratory".

ASLM2018 will take place at the Transcorp Hilton, in Abuja, Nigeria, from 10-13 December 2018. 

Joint UN meeting with manufacturers of health products - September 2018

Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in vitro diagnostics products, vaccines, finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control products will take place 24-27 September 2018 at the UN City (Marmorvej 51, 2100 Copenhagen, Denmark).