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Saatja: <[email protected]> Saadetud: 07.11.2022 11:26 Adressaat: <[email protected]> Koopia: <[email protected]> Teema: Newsletter November 2022 Manused: image002.jpg Dear national competent authorities for blood, tissues & cells and organs, We have collected for you some updates on recent activities, general news and information about next meetings. 1. Proposal for a SoHO regulation The negotiations in Council are ongoing with the health attachés of each of the EU-27 Member States and under the leadership of the Czech Presidency. The process is steadily moving ahead. For further information you can talk to your national representative. The European Parliament has nominated Ms Nathalie Colin-Oesterlé (EPP/FR) as Rapporteur. Nicolás González Casares (S&D/ES), Tilly Metz (EFA/LU), Joanna Kopcińska (ECR/PL), Kateřina Konečná (The Left/CZ) and Andreas Glück (Renew/DE) were nominated as shadow rapporteurs. Ms Colin-Oesterlé confirmed the planned timeline to present her report to the ENVI committee in January with a view to a committee vote in February. 2. EU funding and EU4Health calls EuMAR grant agreement was signed. The project will start on 1st of January 2023. The European monitoring of Medically Assisted Reproduction project is led by the European Society of Human Reproduction and Embryology (ESHRE) and involves also NCAs and patients’ organisations. The ultimate goal of EuMAR is to provide the different stakeholders with high quality data to quantify the effectiveness and safety of current and new technologies in MAR, including fertility preservation. EuroTraCTOR grant agreement was signed. The project will start on 1st of January 2023. The European Transplant and Cellular Therapy Online Registry – led by the European Society for Blood and Marrow Transplantation (EBMT) with eleven partnering centres and a total of 56 professionals covering 6 EU Member States. A new EBMT registry will be built based on the needs identified by HSCT professionals and NCAs, and aims to be as flexible as possible and user-friendly. 3. Update of SoHO Website The European Commission SoHO website (https://health.ec.europa.eu/blood-tissues-cells-and- organs_en) has been updated recently to adapt to the corporate look and feel. As part of these changes, the content has been reorganised. The actions funded by the Commission are now collected in a single PDF in the Implementation page under Ongoing and completed EU funded actions. Projects are divided by subject and ordered chronologically. Feel free to have a look and let us know if you find mistakes or missing initiatives. 4. EDQM Vacancy notice Please note the following vacancy notice for a Senior Project Officer – Substances of Human Origin to support the SoHO activities has been published on the Council of Europe website: https://urldefense.com/v3/__https://www.coe- recruitment.com/JobDetails.aspx?vacancyID=1972&Lang=En__;!!DOxrgLBm!CNpE33Foj3uBcunUIbAc5G gmGnzAEfxT8uepBWW2U9LutZxo7I3K5Bl2kGNMLx3G9D9ONq5U1ApKUjOWAwdBBVSGpdBN$ Feel free to share it with your networks and anyone who might be interested. The deadline is on 14 November 2022. For further information, please directly contact the Council of Europe at [email protected]. 5. Meetings of the National Competent Authorities 2023: save the dates! As explained during the last teleconference, we would like to organise our meetings of the National Competent Authorities in a more effective, and regular, way: - Regular informative meetings, during which updates and reports from Agencies and International Organisations, update on EU funded activities or recurring topics are presented, will be organised on-line - Participative meetings involving more brainstorming, interactions and feedback from and among participants will be organised in presence. The meetings of the National competent authorities planned for 2023 are the following (note that each meeting is subject to confirmation): - Virtual meetings of the blood, tissues & cells and organs competent authorities • 18 January • 24 May • 20 September - Face to face meeting of the tissues and cells competent authorities • 08/09 February - Face to face meeting of the blood competent authorities • 15/16 June - Face to face meeting of the organs competent authorities • 25/26 October 6. EBA tool for seriousness assessment of blood donor adverse reactions The information on the planned pilot (in 2023) of the European Blood Alliance endorsed tool for seriousness assessment of blood donor adverse reactions was shared with the Competent Authorities for blood. In attachment you can find the “final” pdf version of the summary document. It shows all the relevant information about the data collection table. This is actually unchanged from the word version you have received as it was not possible to add a print screen of the SARE webform as initially planned. If you wish to reach the SoHO team, please contact us at [email protected]. Best wishes, 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] <[email protected]> Saaja: [email protected], [email protected] Teema: Newsletter November 2022 Dear national competent authorities for blood, tissues & cells and organs, We have collected for you some updates on recent activities, general news and information about next meetings. 1. Proposal for a SoHO regulation The negotiations in Council are ongoing with the health attachés of each of the EU-27 Member States and under the leadership of the Czech Presidency. The process is steadily moving ahead. For further information you can talk to your national representative. The European Parliament has nominated Ms Nathalie Colin-Oesterlé (EPP/FR) as Rapporteur. Nicolás González Casares (S&D/ES), Tilly Metz (EFA/LU), Joanna Kopcińska (ECR/PL), Kateřina Konečná (The Left/CZ) and Andreas Glück (Renew/DE) were nominated as shadow rapporteurs. Ms Colin-Oesterlé confirmed the planned timeline to present her report to the ENVI committee in January with a view to a committee vote in February. 1. EU funding and EU4Health calls EuMAR grant agreement was signed. The project will start on 1st of January 2023. The European monitoring of Medically Assisted Reproduction project is led by the European Society of Human Reproduction and Embryology (ESHRE) and involves also NCAs and patients’ organisations. The ultimate goal of EuMAR is to provide the different stakeholders with high quality data to quantify the effectiveness and safety of current and new technologies in MAR, including fertility preservation. EuroTraCTOR grant agreement was signed. The project will start on 1st of January 2023. The European Transplant and Cellular Therapy Online Registry – led by the European Society for Blood and Marrow Transplantation (EBMT) with eleven partnering centres and a total of 56 professionals covering 6 EU Member States. A new EBMT registry will be built based on the needs identified by HSCT professionals and NCAs, and aims to be as flexible as possible and user-friendly. 1. Update of SoHO Website The European Commission SoHO website (https://health.ec.europa.eu/blood-tissues-cells-and-organs_en) has been updated recently to adapt to the corporate look and feel. As part of these changes, the content has been reorganised. The actions funded by the Commission are now collected in a single PDF in the Implementation page under Ongoing and completed EU funded actions<https://health.ec.europa.eu/document/download/2c0c9bf1-b2be-4d4c-8df5-48508de2cc05_en?filename=btco_project-list_en_1.pdf>. Projects are divided by subject and ordered chronologically. Feel free to have a look and let us know if you find mistakes or missing initiatives. 1. EDQM Vacancy notice Please note the following vacancy notice for a Senior Project Officer – Substances of Human Origin to support the SoHO activities has been published on the Council of Europe website: https://urldefense.com/v3/__https://www.coe-recruitment.com/JobDetails.aspx?vacancyID=1972&Lang=En__;!!DOxrgLBm!CNpE33Foj3uBcunUIbAc5GgmGnzAEfxT8uepBWW2U9LutZxo7I3K5Bl2kGNMLx3G9D9ONq5U1ApKUjOWAwdBBVSGpdBN$<https://urldefense.com/v3/__https:/www.coe-recruitment.com/JobDetails.aspx?vacancyID=1972&Lang=En__;!!DOxrgLBm!CNpE33Foj3uBcunUIbAc5GgmGnzAEfxT8uepBWW2U9LutZxo7I3K5Bl2kGNMLx3G9D9ONq5U1ApKUjOWAwdBBVSGpdBN$> Feel free to share it with your networks and anyone who might be interested. The deadline is on 14 November 2022. For further information, please directly contact the Council of Europe at [email protected]<mailto:[email protected]>. ​ 1. Meetings of the National Competent Authorities 2023: save the dates! As explained during the last teleconference, we would like to organise our meetings of the National Competent Authorities in a more effective, and regular, way: * Regular informative meetings, during which updates and reports from Agencies and International Organisations, update on EU funded activities or recurring topics are presented, will be organised on-line * Participative meetings involving more brainstorming, interactions and feedback from and among participants will be organised in presence. The meetings of the National competent authorities planned for 2023 are the following (note that each meeting is subject to confirmation): * Virtual meetings of the blood, tissues & cells and organs competent authorities • 18 January • 24 May • 20 September * Face to face meeting of the tissues and cells competent authorities • 08/09 February * Face to face meeting of the blood competent authorities • 15/16 June * Face to face meeting of the organs competent authorities • 25/26 October 1. EBA tool for seriousness assessment of blood donor adverse reactions The information on the planned pilot (in 2023) of the European Blood Alliance endorsed tool for seriousness assessment of blood donor adverse reactions was shared with the Competent Authorities for blood. In attachment you can find the “final” pdf version of the summary document. It shows all the relevant information about the data collection table. This is actually unchanged from the word version you have received as it was not possible to add a print screen of the SARE webform as initially planned. If you wish to reach the SoHO team, please contact us at [email protected]<mailto:[email protected]>. Best wishes, The SoHO team. [cid:[email protected]] 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