Innovation in Blood Establishment Processes, Strasbourg, 2025: a Conference Report.

This report highlights the main topics discussed during the international EDQM Blood Conference on Innovation in Blood Establishment Processes, hosted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe in Strasbourg, France on 14-15 January 2025. The shift from the existing European Union (EU) directives to the new Substances of Human Origin (SoHO) Regulation (EU) 2024/1938 in 2027 will allow a more unified approach across the EU. It will establish measures to set high quality and safety standards for SoHO intended for human applications, thus ensuring high levels of health protection for donors and recipients while strengthening the continuity of the supply of critical SoHO. This conference was an opportunity for participants to share and discuss experiences and innovation in blood donation and blood components. It also raised awareness of the benefits and challenges in implementing the new SoHO Regulation in the blood transfusion field.