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PLASTIC RECONSTRUCTIVE AND REGENERATIVE SURGERY

Commentary

Vol. 24 No. 1 (2026): Blood Transfusion 1-2026 (January-February)

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

Authors

Marie Pflieger , Annika Sepich , Julie Harriague , Margarida Amil , Nigar Ertuğrul Örüç , Tor Audun Hervig , Ína Björg Hjálmarsdóttir , Lene Holm Harritshøj , Luca Mascaretti , Simonetta Pupella , Harald Schennach , Stephen Vardy , Tomislav Vuk , Perrine Arnould , Rada M. Grubovic Rastvorceva , Richard Forde , Marie Emery

Key words: blood donation, blood components, best pratices, diffusion of innovation
DOI: 10.2450/BloodTransfus.1088
Therapies based on substances of human origin (SoHO)
Publication Date: 2025-10-03

Abstract

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.

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Authors

Marie Pflieger - European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France https://orcid.org/0009-0003-7295-2852

Annika Sepich - European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France https://orcid.org/0000-0002-1097-9254

Julie Harriague - P95 Clinical and Epidemiology Services, Leuven, Belgium https://orcid.org/0000-0001-6824-9169

Margarida Amil - Instituto Português do Sangue e da Transplantação, Porto, Portugal

Nigar Ertuğrul Örüç - Blood Transfusion Centre, University of Health Sciences Diskapı Yildirim Beyazit Training and Research Hospital, Ankara, Türkiye https://orcid.org/0000-0002-8848-5545

Tor Audun Hervig - Stavanger University Hospital, Stavanger, Norway

Ína Björg Hjálmarsdóttir - The Blood Bank, Landspitali University Hospital, Reykjavík, Iceland

Lene Holm Harritshøj - Rigshospitalet, Department of Clinical Immunology, Copenhagen Blood Centre, Copenhagen, Denmark

Luca Mascaretti - Deputy Editor, Blood Transfusion, Milan, Italy https://orcid.org/0000-0002-1466-265X

Simonetta Pupella - National Blood Centre, Istituto Superiore di Sanità, Rome, Italy

Harald Schennach - Central Institute for Blood Transfusion and Dept. of Immunology (ZIB), Tirol Kliniken GmbH, Innsbruck, Austria https://orcid.org/0009-0005-8536-8780

Stephen Vardy - NHS Blood and Transplant, Barnsley, United Kingdom

Tomislav Vuk - Croatian Institute of Transfusion Medicine, Zagreb, Croatia https://orcid.org/0000-0001-9951-6119

Perrine Arnould - European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France

Rada M. Grubovic Rastvorceva - European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France https://orcid.org/0000-0002-4885-3323

Richard Forde - European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France https://orcid.org/0009-0000-1140-4498

Marie Emery - European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France https://orcid.org/0009-0003-9982-3532

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