- 10:45 - 13:15
- Palazzo Salviati - Auditorium
Session 2 – Regulatory architecture, oversight, and evidence - SoHO under pressure: blood & plasma supply, preparedness and emergency response
This high-level panel examines how the new EU Regulation on Substances of Human Origin (SoHO) can be implemented to ensure safety, quality, sufficiency, preparedness, and public trust, while at the same time enabling innovation and effective cross-border cooperation in trauma care, massive haemorrhage, and emergency response.
The discussion will address the implementation of the SoHO Regulation from regulatory, operational, and stakeholder perspectives, highlighting both challenges and opportunities in routine practice and crises. While grounded in the European framework, the panel will emphasize the broader relevance of the SoHO approach also for the international community, recognising that lessons learned in Europe can support global preparedness, humanitarian response, and the strengthening of trauma and transfusion systems worldwide.
10:45 – 11:00 Moderators Intro and panel structure
11:00 – 12:45 Panel Discussion
1.National Implementation and Regulatory Convergence, including Safety, Quality, and Risk-Based Regulation
2. Preparedness, Sufficiency, and Surge Capacity
3. Cross-Border Cooperation and Interoperability
4. Innovation Enablement and Evidence Generation
5. Walking Blood Banks and Non-Conventional Supply Models
12:45 – 12:55 Moderators wrap-up
12:55 – 13:05 Conference take-home messages
13:05 – 13:15 Closing remarks