Assuring the quality of in vitro diagnostics (IVDs): WHO Prequalification of IVDs (PQDx) and Emergency Use Assessment and Listing (EUAL)
World Health Organization
No invitations necessary; open to all conference registrants
Wednesday 7 December
19:00 – 20:30
CTICC room location: 1.6
Manufacturers of IVDs, procurement agencies, policy makers, national disease programme managers, managers of laboratories and other testing services.
The WHO Prequalification of In Vitro Diagnostics (PQDx) aims at ensuring the quality of commercially available IVDs through a comprehensive process including a review of the product dossier to support manufacturers’ claims, a performance evaluation to verify performance and operational characteristics and an on-site inspection to assess the quality management system under which products are manufactured. In settings where regulatory capacity is lacking, the outcomes of the prequalification process may provide a source of unbiased, scientifically sound evidence to inform procurement decisions for a continuously expanding range of analytes.
The Emergency Use Assessment and Listing (EUAL) procedure was developed in 2014 in response to the largest Ebola epidemic in history, affecting multiple countries in West Africa. The aim of the procedure is to assess candidate IVDs needed as part of the response to a Public Health Emergency of International Concern (PHEIC) and to expedite their availability. It is intended to advise interested procurement agencies and Member States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data. On 5 February 2016, the EUAL procedure was expanded to include IVDs intended for Zika virus disease diagnosis.
WHO will present an update on the WHO Prequalification of IVDs and will present the work performed under the EUAL procedure for Ebola and Zika virus diseases.
SESSION LEARNING OBJECTIVES:
- Briefing on the progress and expansion of WHO Prequalification of In Vitro Diagnostics,
- Presentation of the Emergency Use Assessment and Listing procedure (EUAL): work performed for Ebola IVDs and progress on Zika virus IVDs.
Irena Prat, World Health Organization, Group Lead
Irena Prat leads the diagnostics assessment group within the WHO Prequalification Team. Before joining WHO she was a medical devices regulator with the national regulatory authority for medical devices in Slovenia. She has been contributing to the prequalification of in vitro diagnostics since 2008. Her educational background covers both laboratory biomedicine and international management.
Robyn Meurant,World Health Organization, Technical Officer
Robyn Meurant is a medical scientist by training. She has run large serology laboratories and was a regulator of in vitro diagnostics for the Therapeutic Goods Administration in Australia. She joined the diagnostics assessment group of what is now the WHO Prequalification Team in 2012. Her main responsibilities include coordination of applications to prequalification, dossier screening and review, and review of changes to products. She has also been involved in the WHO assessment of Ebola diagnostics associated with the current outbreak of Ebola virus disease in West Africa and the development of guidance for use of these products.
Joel Kuritsky, United States Agency for International Development, Medical Advisor and Technical Team Lead for the Supply Chain for Health Division
Medical Advisor and Technical Team Lead for the Supply Chain for Health Division at USAID; trained in internal medicine and infectious diseases with over 30 years experience working in the public sector for USAID and CDC. Current interests include diagnostic product quality assurance, scale up of viral load and early infant diagnosis, and collaboration with partners in the Global Diagnostic Working Group.