IMDRF 2023

23rd session

27-28 March 2023 | Brussels, Belgium

Irena Prat

Team Lead, In vitro diagnostics Assessment, World Health Organization

Prior to joining the World Health Organization Ms Prat served as a medical devices Counsellor at the Agency for Medicinal products and Medical Devices of the Republic of Slovenia. She was in charge of several pre- and post-market activities, including pre-market registration procedures, vigilance and educational programs for stakeholders.

In March 2008 Ms Prat joined WHO’s Diagnostics and Laboratory Technology team, where she was involved in the implementation of the prequalification programme for in vitro diagnostics, with emphasis on the product dossier component of the programme. Since 2014 she leads the In vitro diagnostics assessment team within the Prequalification Unit and take primary responsibility for the technical and managerial aspects of the programme. She coordinate WHO’s prequalification assessments of IVDs, normative and guidance work in support of the Prequalification of in vitro diagnostics programme, supports Member States and other stakeholders on matters relating to in vitro diagnostics, provides technical leadership among United Nations agencies for matters relating to in vitro diagnostics and coordinates WHO contribution to global and regional harmonization initiatives on in vitro diagnostics such as the International Medical Device Regulators Forum (IMDRF).

Ms Prat holds a degree in laboratory biomedicine and a post-graduate degree in management.