The PQT-IVD team held a joint assessment session from 5-9 June in Geneva session to pilot a new assessment model whereby assessors meet for a week during which they work in groups to assess product dossiers and change requests. In addition to reviewing manufacturer applications, key objectives of the assessment session were to share expertise among assessors, strengthen the assessment capacity and develop a robust workplan for future sessions. The pilot session brought together 21 subject matter experts to review product dossiers and change requests for prequalified IVDs.
Feedback from the assessors was favourable for the group approach, which provides the opportunity to discuss and resolve issues as they arise and facilitates more standardized reporting. Experts that are new to PQ product dossier assessment found working in a team with more experienced assessors to be a supportive and beneficial experience. Suggestions for ideal group sizes, structure of the work schedule and timing of pre-reading have also been received to help optimise the workplan for the next three joint assessment sessions scheduled for this year. The PQT-IVD are very appreciative of the time and energy of the experts that participated in the pilot and look forward to working with them in the future assessment sessions.