WHO workshop on Prequalification of In Vitro Diagnostics (IVDs) for national regulatory authorities (NRAs): assessment of stability studies for IVDs
Sponsors: World Health Organization
Date: Monday, 10 December 2018
No invitations necessary; open to all conference registrants
Building on ongoing efforts in many low and middle income countries to establish reliable regulatory systems with a clear mandate and sufficient capacity to regulate in vitro diagnostics (IVDs), the WHO Prequalification of In Vitro Diagnostics (WHO PQDx) is proposing to conduct a workshop for NRAs in order to present the work conducted to ensure the quality, safety and performance of IVDs entering these markets. In the current regulatory landscape, the WHO prequalification assessment and its outcomes serve as a mark of quality for IVDs in markets outside of the scope of stringent regulatory authorities and is based on best international practice.
The prequalification assessment process includes three components:
- Review of a product dossier,
- Laboratory evaluation of performance and operational characteristics, and
- Manufacturing site(s) inspection.
Post-qualification activities undertaken by WHO PQDx 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.
The seminar will focus on stability studies for IVDs and will introduce assessment principles to regulators from EAC jurisdictions, based on international best practice.
- Irena Prat, World Health Organization, Prequalification of In Vitro Diagnostics