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Saatja: <[email protected]> Saadetud: 26.05.2023 11:47 Adressaat: <[email protected]>; <[email protected]>; Almén, Helena <[email protected]> Teema: Follow-up EU informal Organs CA meeting Stockholm Manused: image001.jpg Dear National Competent Authorities for Organs, dear colleagues, First of all, we would like to thank once again Helena Almén from the National Board of Health and Welfare for welcoming us in Stockholm and hosting the informal meeting last week, and thank those of you who participated. The presentations given during the event are now available on CircaBC. Additionally, we would like to remind you about: - the EU-wide EU Survey questionnaire about the state of Organs SAE/SAR reporting in your Member State. All Organs National Competent Authorities are kindly requested to respond to this survey. Your information is important, even if you are not able to participate in the voluntary pilot data collection exercise (line below). - the pilot conducted by the Vigilance Expert sub-group to collect national level Organ SAE/SAR data via the excel file provided in the attached email. Your participation to this pilot is voluntary. Please forward the excel file with the related documents to your delegated body if they will be participating on your country’s behalf and inform SANTE-SoHO of the relevant contact details. The deadline to submit both documents is extended to the 15 June 2023. The face to face meeting of the competent authorities for organs and organs transplantation scheduled on 25/26 October 2023 is cancelled. The next opportunity to meet in person will be the “Global Summit - Towards global convergence in transplantation: sufficiency, transparency & oversight” organised by the Spanish Competent Authority in Santander (9-10 November) as part of the events linked to the Spanish Presidency of the Council of the EU. We’ll speak again with all of you and the competent authorities for blood, tissues and cells tentatively on 20 September 2023 for the another virtual joint meeting. Additional virtual meetings dedicated only to the competent authorities for organ might be organized if needed. Thank you for your cooperation. Kind regards, The 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 Saatja: [email protected] Saaja: [email protected] Teema: Invitation: Survey of state of Organs vigilance and pilot of Organ SAE/SAR data collection 2023 (2022 data) Kuupäev: 2023-03-31 07:46 Dear national competent authorities for organs, This is to inform you of an EU-wide <https://ec.europa.eu/eusurvey/runner/325b3db5-98c2-e179-7804-6f1926aa2f31> EU Survey questionnaire about the state of Organs SAE/SAR reporting in your member states. All Organs National Competent Authorities are kindly requested to respond to this survey by 31 May 2023. Your information is important, even if you are not able to participate in the voluntary pilot data collection exercise. In addition, we are glad to inform you of the launch of the pilot of European level submission of nationally collected Serious Adverse Events and Serious Adverse Reactions, as required under the Organs Directive 2010-45. The pilot is being conducted under the auspices of the department of Substances of Human Origin (SoHO) of the European Commission, by the Vigilance Expert Subgroup (VES) of the expert group of National Competent Authorities (NCA). The attached pilot summary provides background information. We now invite you (if you are able to do so) to submit your national level Organ SAE/SAR data using the tables (1, 2a, 2b) in the attached Excel file. This invitation is being sent to you as NCA. Please forward it with the attached documents to your delegated body if they will be participating on your country’s behalf and inform SANTE-SoHO of the relevant contact details. Deadline for SARE submission (NCA or delegated body): 31 May 2023. If you have any questions, do not hesitate to contact us at <mailto:[email protected]> [email protected] Best regards, The 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