Update on WHOP requalification
Sponsors: World Health Organization
Date: Tuesday, 11 December 2018
No invitations necessary; open to all conference registrants
Manufacturers of IVDs, procurement agencies, policy makers, national HIV programme managers, managers of laboratories and other testing services
The WHO Prequalification of In Vitro Diagnostics (PQDx) aims at ensuring access to the commercially available IVDs through a comprehensive assessment of quality, safety and performance. The process includes a review of the product dossier that supports manufacturers’ claims, an independent laboratory evaluation to verify performance and operational characteristics and an on-site inspection to assess the quality management system under which products are manufactured. The outcomes of the prequalification assessment provide a source of unbiased, scientifically sound evidence to assist countries lacking regulatory capacity in making procurement decisions for a continuously expanding range of analytes.
WHO will present an update on the WHO Prequalification of IVDs including its newly implemented alternative performance evaluation mechanism and the work that has been performed to expand the laboratory network supporting its work, as well the different guidance documents that have been produced to assist manufacturers in meeting WHO requirements. WHO will also present the collaborative procedure to facilitate in country registration of prequalified IVDs.
SESSION LEARNING OBJECTIVES:
- Briefing stakeholders on the progress and expansion of WHO Prequalification of In Vitro Diagnostics
- Irena Prat, World Health Organization, Prequalification of In Vitro Diagnostics