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Department of Biological Standardisation, OMCL Network & HealthCare (DBO) Substances of human origin (SoHO) Quality section Dear colleagues, (competent authorities) The Council of Europe / European Directorate for the Quality of Medicines & HealthCare (EDQM, www.edqm.eu/en), is conducting a project aimed at strengthening biovigilance programmes for organs, tissues and cells for human application. This project is co-funded by the EDQM and the European Commission. The expected outcome is the improvement of the quality and safety profile of organs, tissues and cells in Europe through the identification and implementation of best biovigilance practices for professionals, and reinforced biovigilance programmes in Council of Europe / European Union member states. The first step in this project will be to evaluate the state-of-play of biovigilance programmes currently in place in Europe, by carrying out a survey intended for all competent authorities in the fields of organs and tissues and cells. This survey should help the project team to draw a precise and comprehensive overview of biovigilance systems in place in Europe. The data collected will be used to support the development of best practice guidance for professionals responsible for the implementation and the management of effective and efficient biovigilance programmes. We would be deeply grateful if you, as a competent authority, could take the time to reply to this questionnaire, available here: http://survey.edqm.eu/index.php?r=survey/index&sid=762678&lang=en. This should take you 10 – 20 minutes. If there are different competent authorities for organs and tissues and cells in your country, we ask you to have one survey filled in for each of them (by the appropriate persons). It is of utmost importance hear your feedback. This will enable us to evaluate your needs and constraints and to hear your opinion on different aspects of biovigilance, in order to provide relevant and useful best practice guidance. Once consolidated, your answers will be used as a basis for a state-of-play report, the ensuing best practice guidance preparation and a later publication. In addition, we will send you another email later today containing a second survey, which aims at gathering input from the professionals in the field about how they implement biovigilance programmes in practice. We would be deeply grateful if you could disseminate this email as widely as possible upon receipt to all the professionals involved in biovigilance activities in your country (tissue establishments, procurement organisations, hospitals, medically assisted reproduction clinics, etc.). The deadline for completing the surveys is set on 21 January 2024. Should you have any questions, please do not hesitate to contact us at [email protected]. Thank you in advance and kind regards On behalf of the Biovigilance working group, The SoHO Quality section Saatja: [email protected] Saaja: [email protected] Teema: Biovigilance survey - EDQM Kuupäev: 2023-12-20 14:23 Dear Competent Authorities for tissues and cells, and for organs, Please find attached a message from the colleagues in EDQM asking you to participate in a survey on biovigilance by 21st of January. This survey is part of a joint EDQM/SANTE action, aim is to build an overview on the biovigilance systems in place for organs, tissues and cells, within your countries. Where it regards tissues and cells, we feel this exercise is very timely, with the agreement on the new SoHO regulation, to obtain a good common overview on the status of the different vigilance system. SANTE is starting reflections on how to best support Member States’ authorities preparing for the implementation of the new SoHO regulation, and SANTE will therefore use the results of this survey to build an understanding on the needs of authorities in this area. We therefore invite you to participate and share your views and needs openly through this survey. Please note that the 2024 EU4Health action includes significant support to help Member States with their preparations to implement the new SoHO regulation, in particular to implement the different (new) oversight tasks (vigilance, traceability, registration of entities and authorisation of establishments, authorisation of SoHO preparations, data collection, …). We therefore expect that, as from early 2024, you will receive some further surveys in order to help us understand the status and needs for these different oversight tasks, and to make sure we help you prepare at best. We wish you a very nice Christmas break, and look forward to continuing our collaboration in 2024. The (SANTE) SoHO team European Commission DG SANTE (Health and Food Safety) Unit D2 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium <http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm> http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm