On Wednesday 21 September 2022, a Virtual Workshop was held with manufacturers interested in applying for WHO-Prequalification (PQ) assessment of IVDs used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis. Over 120 participants representing 48 manufacturers as well as other interested stakeholders took part. The focus of the workshop was introducing PQ technical specifications TSS-17, the topics covered are outlined in the Workshop agenda below.
|
Topic |
Presenter / Facilitator |
|
Welcome and Opening Remarks |
Nazir Ismail (WHO Global TB Programme) Deus Mubangizi (WHO Prequalification Unit) |
|
Overview of PQ |
Irena Prat |
|
Technical Specifications: TSS-17 |
Ute Ströher and Deirdre Healy |
|
Product Dossier Assessment |
Mark Lanigan |
|
Performance Evaluation |
Anne-Laure Page |
|
Site Inspection |
Stephanie Croft |
|
Q&A |
Susie Braniff |
|
Wrap-up & Close |
Irena Prat |
The PQ-IVD Assessment Team would like to thank the participants for their interest and engagement and invite manufacturers of IVDs used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis to apply for WHO Prequalification.
A pre-submission call can be requested by emailing the PQ-IVD Team (diagnostics@who.int).
A recording of the Workshop can be accessed using the following link:
- https://who.zoom.us/rec/share/mdjt54sIDzVcAV5pbdfME46lK38ndn3YrTN_RIz1REGS8GcYxAzm0gycskM4ZjX7.OofsfBnqJ5tFyXke
- Passcode: jEi.Pf2%