|Date & Time||16 May 2023 (15:00 to 18:30 CET)|
|Location||Online and in-person (Amsterdam, The Netherlands)|
The Committee for Advanced Therapies (CAT) will hold a stakeholder meeting on Tuesday 16 May 2023 from 15:00 to 18:30 CET. The meeting will be held in hybrid mode with both physical (at the EMA office in Amsterdam) and virtual attendance (via Webex).
In preparation of the meeting, interested parties from industry and academia are invited to submit topics for discussion at the meeting by 15 March 2023 at AdvancedTherapies@ema.europa.eu (please put ‘CAT stakeholder meeting’ in the subject field).
Based on the suggestions, topics of common interest will be selected. CAT has already identified the topics below that could be included in the agenda but this is not a comprehensive list:
- CTIS and the Clinical trial regulation: bottlenecks for ATMP trials in EU?
- Registries and long-term follow-up: what is your experience?
- NAS reflection paper (see: Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances (europa.eu)): initial feedback from stakeholders
- Health Technology Assessment Regulation (Regulation (EU) 2021/2282): what would you see as special considerations for the Joint clinical assessment of ATMPs?
- Predictability of submission of marketing authorisation applications: even though this might not be ATMP specific issue, CAT would like to know if there are any specific reasons why marketing authorisation applications for ATMPS are often postponed by month or even years.
Additional preparatory teleconference calls might be organised in April 2023 to discuss the agenda and identify speakers/presenters from CAT and the stakeholders.
If you have any questions, please do not hesitate to contact: AdvancedTherapies@ema.europa.eu.