The In Vitro Diagnostics Assessment Team has established a new assessment model combining assessment sessions and between-assessment session work. After a successful pilot project in 2023 six in-person assessment sessions were organized in 2024. In 2025 six assessment sessions will take place and will gather subject matter experts who will assess product dossiers, dossier amendments and change requests. ERPD reviews may be included in specific sessions depending on the overall workload and assessment timelines.
The outputs of the assessment sessions will include several assessment reports across product dossier reviews and change request reviews. In addition, NRA representatives from countries developing their regulatory capacity for in vitro diagnostics will attend the sessions as part of their capacity building.
Meeting objectives includes:
- Assess product dossiers for prequalification
- Assess product dossier amendments for prequalification
- Assess change requests
- Assess ERPD applications
- Share expertise among assessors and NRA representatives
- Strengthen the assessment capacity through new expert's introduction
- Further streamline and standardize assessments
The assessment session will allow the team to continue implementing the new assessment model combining assessment sessions and between-session assessment work. Several assessment reports will be written by experts, spanning across new product dossier assessments, assessments of dossier amendments, assessment of change requests and ERPD applications.
Dates of the sessions:
- 10 to 14 February 2025
- 7 to 11 April 2025
- 16 to 20 June 2025
- 25 to 29 August 2025
- 13 to 17 October 2025
- 8 to 12 December 2025