European Project adressing the safety
of blood transfusion

 

 

Project Cooperations, Publications and selected Training Seminars* of the Project participants (related to the Public Health Programme and the outcomes of EuBIS):
*further seminars and trainings are listed under the section, EuBIS Academy


1. European Blood Inspection Project (EuBIS) Manual: Normas y criterios comunes europeos para la inspeccion de centros de transfusion sanguinea, Informes, Estudios E Investigacion, Seidl C, Seifried E (Editoren) JM Cardenas (Spanish Editor): Published by the Ministerio De Sanidad, Politica Social E Igualdad, Spain, 2011

2. European Blood Inspection Project (EuBIS) Inspection/audit training guide: Guia de formacion sobre auditoas/inspecciones incluida decomentacion preliminar. Informes, Estudios E Investigacion, Seidl C, Seifried E (Editoren) JM Cardenas (Spanish Editor): Published by the Ministerio De Sanidad, Politica Social E Igualdad, Spain, 2011

3. The EuBIS manual and training guide: Guidelines and standards for quality management and inspection of blood establishments. Seidl C., Kaltenbrunner-Bernitz B., Skrablin P., Cermakova Z., Delaney F., Teskrat F., Jansen van Galen JP., Huber Hm., Nightingale M., MacMillan Douglas A., Baroti-Toth k., Ceulemans J., Hinloopen B., Siegel W., Sobaga L., Grazzini G., De Wit J., Seifried E. 21st Regional Congress of the International Society of Blood Transfusion (ISBT) Europe, Lisbon, 18-22 June 2011, Portugal, Vox Sang, 101 (suppl. 1), P-669, p345.

4. Blood collection and processing. Quality guidelines and standards reflecting common best practice standards referring to the EuBIS manual and guide. Seidl C, Huber H, Müller-Kuller T, Sireis W, Aquilina A, Barotine-Toth K, Cardenas JM, Ceulemans J, Cermakova Z, Delaney F, Jansen van Galen JP, Grazzini G, Hinloopen B, Heiden M, Nightingale M, Pupella S, Sobaga L, Teskrat F, deWit J, Seifried E. 32nd International Congress of the ISBT hosted by the Mexican professional community of blood transfusion represented by the “Asociación Mexicana de Medicina Transfusional AC” (AMMTAC), July 7-12, 2012 in the Cancun Convention Centre, Mexico, Vox Sanguinis – Science Series, 201, 2012

5. Competent authority – Training Programme for inspectors on blood establishments in Europe funded by the EC, Contract No. 2011/S 167-27519 (DG Sanco/EAHC). 1st CATIE Workshop Organized by the CATIE Consortium under the auspices of the European Commission, DG SANCO, Call for Tender EAHC/2011/Health/13, Hosted by the National Hungarian Blood Service, 28th – 31st of August, 2012.

6. Training sessions for inspectors in the field of blood and blood components (CATIE). Ed.: Seidl C, Seifried E on behalf of the CATIE consortium (Grazzini G, CNS, Italy, Amil M, IPST, Portugal, Teskrat F (ASNM), France, Seitz R (PEI) Germany, Moro E (MSSSI), Spain). In: Transplantation and Transfusion, projects and actions for saving and improving the quality of life of citizens by facilitating transplantation and blood transfusion in the European Union, ISBN 978-92-9200-0202-2, European Union, 2013.

7. Competent authority – Training Programme for inspectors on blood establishments in Europe funded by the EC, Contract No. 2011/S 167-27519 (DG Sanco/EAHC). 2nd CATIE Workshop Organized by the CATIE Consortium under the auspices of the European Commission, DG SANCO, Call for Tender EAHC/2011/Health/13, Hosted by the Ministerio de Sanidad, Servicios Sociales e Igualdad and the Centro Vasco de Transfusión y Tejidos Humanos, Bilbao, Spain, 4th-8th of March 2013.

8. Competent authority – Training Programme for inspectors on blood establishments in Europe funded by the EC, Contract No. 2011/S 167-27519 (DG Sanco/EAHC). 3rd CATIE Workshop Organized by the CATIE Consortium under the auspices of the European Commission, DG SANCO, Call for Tender EAHC/2011/Health/13, Hosted by the Directorate of Health Care Services Standards, Government of Malta, Valettaand the The National Blood Transfusion Service (G’Mangia), Centru Nazzjonali ta't-Trafuzjoni tad-Demm, 29th April – 3rd of May 2013.

9. Competent authority – Training Programme for inspectors on blood establishments in Europe funded by the EC, Contract No. 2011/S 167-27519 (DG Sanco/EAHC). 4th CATIE Workshop Organized by the CATIE Consortium under the auspices of the European Commission, DG SANCO, Call for Tender EAHC/2011/Health/13, Hosted by the Italian National Blood Center, the Centro Nazionale Sangue (CNS), Ministry of Health, Istituto Superiore di Sanità (ISS), 24th – 25th of June 2013.

10. Development of a pan-European standard operating procedure (SOP) methodology reflecting European best practice within the area addressing the quality and safety of blood (EU-Q-Blood-SOP). Seidl C, Seifried E (ed.) on behalf of the project partners. In: Transplantation and Transfusion, projects and actions for saving and improving the quality of life of citiziens by facilitating transplantation and blood transfusion in the European Union, ISBN 978-92-9200-0202-2, European Union, 2013.

11. Development of pan-European standards and criteria for the inspection of blood establishments (EU-Blood-Inspection, EuBIS). Seidl C, Seifried E (ed.) on behalf of the project partners. In: Transplantation and Transfusion, projects and actions for saving and improving the quality of life of citiziens by facilitating transplantation and blood transfusion in the European Union, ISBN 978-92-9200-0202-2, European Union, 2013.

12. Competent authority training programme for inspectors of blood establishments in Europe (CATIE). Seidl C, Delaney F, Huber HM (editors on behalf of the CATIE consortium). Facilitator Manual, Edition 1.0, 2013 published by the European Commission, DG SANTE, Team Substances of Human Origin, CATIE - Competent Authority Training of Inspections in Europe (catie-europe.eu), 2013.

13. Competent authority – Training programme for insepctors of blood establishments. Organized by the Project for Technical Assistance for strengthening the blood supply system in Turkey and the EuBIS Academy under the auspices of the Turkish Ministry of Health funded by the European Commission, and the Republic of Turkey, Ankara, 14th-17th of January 2014

14. Quality Management and Inspection of blood and blood componentns following GMP standards and the European directives. Seidl C, Huber H, Teskrat F, Aquilina A, Ceulemans J, Cardenas JM, Amil M, Seitz R, Pupella S, Grazzini G, Vuk T, Strengers P, deWit J, van de Kerckhove P, Seifried E. Lecture at the 25th Regional Congress of the International Society of Blood Transfusion (ISBT) London, United Kingdom, June 27 - July 1, 2015, Vox Sanguinis 109 (Suppl.1), p14, 2015.

15. European Blood Inspection Project (EuBIS) Manual and Inspection/audit training guide on common criteria and standards for the inspection of blood establishments. Seidl C, Seifried E (Editors). Manual published under the Public Health Programme of the European Commission. Including Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments, Revised Edition 1.0.1, September 2016.

16. European Blood Inspection Project (EuBIS) Inspection/audit training guide on common criteria and standards for the inspection of blood establishments. Seidl C, Seifried E (Editors). Manual published under the Public Health Programme of the European Commission. Including Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments, Revised Edition 1.0.1, June 2016.

17. Substances of human origin – Process management and risk assessment related to GP and GMP. (Seidl C.) Seminar and training workshop on behalf of the ISBT Working party on quality management participants and EuBIS Academy at the 34th International Congress of the International Society of Blood Transfusion (ISBT), Dubai, September 3 – 8, 2016

18. Work-Package 6 of the VISTART Joint Action focuses on the development of Guidelines for EU Competent Authorities responsible for the inspection and authorization of blood and tissue establishments. Joint Action VISTART “Vigilance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation” (Grant Agreement No. 676969) This Work Package 6 meeting is co-ordinately organised by the Italian National Blood Centre, Centro Nazionale Sangue (CNS), the Agence Nationale de sécurité du Médicament (ANSM) and the German Red Cross Blood Donation Service (GRCBDS), Institute of Transfusion Medicine and Immunohematology as a collaborating partner. 2015-2017.

19. Pilars in the organization and infrastructure of optimal quality systems in blood transfusion services. Key Note Lecture - Session 3: Step’s required in quality systems in blood establishments, Seidl C. published via IPFA, International Plasma Fractionation Association (IPFA) 2nd Asia Workshop and Meeting, Yoyogarta 2-3- March 2017

20. Quality management and inspection of blood establishments - Seminar and Training Workshop -‘From Good practices to best practices’ in blood and blood components referring to GMP ISBT Award - Workshop and Training on Quality Management – National Institute of Hematology and Blood Transfusion, Hanoi, Vietnam. Organised and hosted by the National Institute of Hematology and Blood Transfusion (NIHBT) with support by the ISBT Working Party on Quality Management and the EuBIS Academy, Vietnam, the 8th – 10th of March 2017

21. Quality monitoring and risk assessment in blood transfusion services. Academy Session (Monday), 28th Regional Congress of the International Society of Blood Transfusion (ISBT), Guangzhou, China, November 25–28, 2017. Lecture published in Vox Sanguinis, Vuk T, Qiu Y, Bust L, Strengers P, Seidl C; Publication: ISBT Science Series (2018), Vox Sanguinis, Article ID: VOXS12418 Article DOI: 10.1111/voxs.12418 Internal Article ID: 14993411 revised version accepted 16. January 2018.

22. Self-inspection and audits based on GMP and GPG preparing for regulatory inspections – the EuBIS experience. Seidl C. Session on Management and Organisation, Quality Management, Abstract ISBT-878, Session Lecture, Vox Sanguinis Special Issue: 35th International Congress of the ISBT, Toronto, Canada, June 2–6, 2018, Volume 113, Issue S1, Pages: 1-368, June 2018.

23. GP/GMP requirements for substances of human origin (SoHO). Seidl C. Lecture ISBT Academy – Workshop and training on quality management – Bangkok, Thailand, Sunday, the 17th of November 2019, Vox Sanguinis, Special Issue:The 30th Regional Congress of the ISBT, Bangkok, Thailand, 16‐19 Nov, 2019, Volume 114, Issue S2, Pages: 1-142, November 2019

24. 'GMP/GP standards and their implication for the safety of blood and blood components. ’Virtual - Training seminar and workshop (ZOOM-Meeting): ISBT Academy – Workshop and training on quality management – ISBT Virtual, Monday, 14th of December 2020

25. Regulatory Capacity Strengthening in Africa funded by the Global Health Protection Program (GHPP) Seminar and training workshop of the African Society for Blood Transfusion (AfSBT) in organized by the Paul-Ehrlich-Institute (PEI and the EuBIS Academy: ‘From Good practices to best practices’ in blood and blood components referring to GPG and GMPQuality management and inspection of blood establishments. hosted by the African Society of Blood Transfusion (AfSBT) and the Western Cape Blood Service, EuBIS#Virtual 8th – 9th of September 2021

26. EU Twinning Project No. GE 18 ENI HE 01 19 ”Strengthening Blood Safety System in Georgia”. Seminar and training workshop organised by the EuBIS Academy, EuBIS#Virtual 31st of March – 1st of April 2022

27. Quality management and inspection of blood establishments - EuBIS Seminar and Training Workshop –‘From Good practices to best practices’in blood and blood components referring to GPG and GMP. Regulatory Capacity Strengthening in Africa funded by the Global Health Protection Program (GHPP). Organised by the Paul-Ehrlich-Institute (PEI), BloodTRain and the EuBIS Academy in cooperation with the African Society of Blood Transfusion (AfSBT) and the Western Cape Blood Service (WCBS), Cape Town, South Africa, 12th – 14th of October 2022

28. European Blood Inspection Project (EuBIS) Inspection/audit training guide on common criteria and standards for the inspection of blood establishments. (Seidl C, Seifried E. (Editors) on behalf of the project partners. Chinese Translation by the Beijing Red Cross Blood Center and the Management Committee of the Chinese Society of Blood Transfusion. Published 2022.

29. Development of a pan-European standard operating procedure (SOP) methodology reflecting European best practice within the area addressing the quality and safety of blood (EU-Q-Blood-SOP). (Seidl C, Seifried E. (Editors) on behalf of the project part Chinese Translation by the Beijing Red Cross Blood Center and the Management Committee of the Chinese Society of Blood Transfusion. Published 2022.

30. Quality management and inspection of blood establishments - EuBIS Seminar and Training Workshop –‘From Good practices to best practices’ in blood and blood components referring to GPG and GMP. Organised by the Beijing Red Cross Blood Center, the Management Committee, Chinese Society of Blood Transfusion and the Nanjing Red Cross Blood Center in cooperation with the EuBIS Academy, EuBIS#Virtual – China – 24th of November 2022.

31. ‘EU funded Support to Ukraine for Developing a Modern Public Health System coordinated by the GFA in consortium with the Finnish Institute for health and welfare. Seminar and training workshop organised by the EuBIS Academy ‘From good practices to best practices’ in blood and blood components referring to GPG and GMP -Strengthening the Blood Safety and Inspection System in the Ukraine. Organised by the EuBIS Academy in cooperation with the EU funded Support to Ukraine for Developing a Modern Public Health System coordinated by the GFA in consortium with the Finnish Institute for health and welfare. Virtual – Programme 7th-8th of March 2023.

32. Seminar and Workshop: GMP/GP standards and their implication for the safety of blood and blood components’. (Seidl C, Tayou C, Bust L, Bowie G, Belairs G, Reinhardt J, Seidl C) by the ISBT Working Party on Quality Management supported by the EuBIS Academy in cooperation with GHP Project ‘Regulatory Capacity Strengthening in Africa, funded by the Global Health Protection Program (GHPP)’ and the Accreditation Programme of the African Society for Blood Transfusion (AfSBT), 34th regional congress of the International Society of Blood Transfusion (ISBT), Cape Town, South Africa, 18th – 21st November 2023, Abstract. Vox Sanguinis, 118: 58, 2023