Recent Activities - 2016
April 2016: 3rd Annual Meeting of WHO Prequalification of IVDs Dossier Assessors and Inspectors
The World Health Organization (WHO) Prequalification Team for Diagnostics promotes access to safe, affordable and high quality test kits that are suitable for use in resource limited settings. Susie Braniff attended the 3rd Annual Meeting of WHO Prequalification of In Vitro Diagnostics (IVDs) Dossier Assessors and Inspectors that was held in Geneva, Switzerland on the 19-21 of April. The objectives of the meeting included the further improvement of WHO site inspection and dossier assessment procedures as well as review of new guidance material for IVD manufacturers and dossier assessors.
During the meeting public comments submitted on the draft documents “Technical Guidance Series-2: Establishing stability of an in vitro diagnostic for WHO Prequalification” and “Requirements for reportable changes to WHO prequalified in vitro diagnostics” were discussed and updates recommended.
Progress was made in the development of a preliminary draft of the technical requirements for HIV rapid diagnostic tests intended for professional and self-use. An update of recent site inspections was delivered followed by discussion of potential operational improvements aimed at continuous improvement of the Prequalification Programme.
The annual three day meeting provides an opportunity for technical experts, laboratory auditors and the WHO Prequalification team to work together refining the process of WHO IVD Prequalification to create a responsive, streamlined and effective programme.