WHO workshop on Prequalification of In Vitro Diagnostics (IVDs) for national regulatory authorities
World Health Organization
Invitations necessary; TBD
Sunday 4 December
13:00 – 17:00
CTICC room location: 2.44-2.46
National regulatory agencies and policy makers.
The lack of regulatory oversight and/or implementation of regulatory frameworks continue to represent a challenge in many countries despite many global and regional efforts to shed a light on the issue and to harmonize regulatory practices. In an effort to fill this gap, the WHO Prequalification of In Vitro Diagnostics (WHO PQDx) undertakes a comprehensive assessment of IVDs through a standardized procedure aimed at assessing their safety, quality and performance.
The prequalification assessment process includes three components:
- Review of a product dossier;
- Performance evaluation and assessment of operational characteristics; and
- Manufacturing site(s) inspection.
Post-qualification activities undertaken by WHO PQ Dx include post-market surveillance and review of mandatory manufacturer notifications of changes to prequalified products and/or the manufacturer’s quality management system.
The outcomes of the prequalification process are used by WHO Member States, UN agencies and international procurement agencies to guide their procurement decisions.
Attendees will be guided through the entire process of prequalification for IVDs from receipt of an application by the manufacturer all the way through to prequalification of the product. The different prequalification components (dossier assessment, manufacturing site inspection, laboratory evaluation, post-qualification activities) will be described in detail. WHO requirements will be explained and participants will have an opportunity to ask specific questions about the process.
SESSION LEARNING OBJECTIVES:
- An introduction for national regulatory agencies to the Prequalification process for IVDs and its requirements.
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.
Willy Urassa, World Health Organization, Scientist
A clinical immunologist, Dr Willy Urassa joined WHO in 2007. His responsibilities with the in vitro diagnostics assessment group of the WHO Prequalification Team include coordination of the laboratory evaluation of HIV, syphilis, hepatitis B, hepatitis C, Ebola serology assays and CD4 technologies. He also provides technical support on quality assurance of laboratory testing.
Anita Sands, World Health Organization, Technical Officer
Anita Sands is responsible for post-market surveillance for in vitro diagnostics and medical devices and facilitating finalisation of prequalification decisions for the Diagnostics Assessment group of the WHO Prequalification Team. She began working for WHO in 2004, evaluating diagnostics for bloodborne serology. She provides technical support related to implementation of testing services for bloodborne viruses to WHO Member States, with a particular emphasis on resource-limited settings. Her specific areas of expertise are product selection, quality assurance and procurement. Previously, she worked as a research scientist and as a laboratory team leader at the National Serology Reference Laboratory, Australia. She has a BSc and an MPH.
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.
Mercedes Perez Gonzalez, World Health Organization, Technical Officer
Mercedes Pérez González is a molecular biologist by training and has been a part of the WHO Prequalification of In vitro Diagnostics since 2007 when she joined as the focal point for molecular technologies. Her main responsibilities include the coordination of the laboratory evaluation component of molecular technologies as well as grant management and communications for IVDs within the WHO Prequalification of IVDs team.