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Saatja: <[email protected]> Saadetud: 23.06.2023 13:00 Adressaat: <[email protected]> Koopia: <[email protected]> Teema: Newsletter June 2023 Manused: image001.jpg; Invitation-agenda_Webinar InfoSession 2023 wave open call-final.pdf Dear national competent authorities for blood, tissues & cells, and organs, We are writing to update you on our recent activities and some more general news. 1. EU4Health 2023 calls for action grants have now been published The 2023 EU4Health calls for action grants have been published and are available at the following link: https://hadea.ec.europa.eu/calls-proposals/2023-eu4health-calls-action-grants_en They include, for SoHO, activities strengthening the implementation of the legislation on blood, tissues and cells and organs and in particular: o action grants on the safety and quality of new substances of human origin for an amount of 400.000 € for each of the two subtopics:  breast milk (EU4H-2023-PJ-08)  faecal microbiota transplants (EU4H-2023-PJ-09) o action grants on facilitating organ paired exchange ((EU4H-2023-PJ-10) for an amount of 600.000€. A dedicated info session will take place on 30 June 2023. More information available at this link: https://hadea.ec.europa.eu/events/info-session-eu4health-2023-open-calls-action-grants-2023-06- 30_en. Please disseminate the information through your network. 2. SARE organ pilot We would like to thank the 15 Member State representatives who have provided data for the SARE organ pilot. We are currently analysing the results and a report will be shared with you. We would like also to thank the 21 Member States representatives who have replied to the EU Survey whose result will be analysed as well. 3. SARE exercise 2023 (2022 data) We kindly remind you that the blood and tissues and cells SARE exercises for 2023 (2022 data) are still open, with a deadline of July 15th 2023 for submission. We ask you, therefore, to make all efforts to prepare for completing your submission within the deadline. The analysis work will be carried out under a time-limited contract by Council of Europe (EDQM). 4. Notification regarding a recently published Federal Register Notice We have received the following Notice from the FDA. You may wish to share it with your establishments if any of them supply tissues or cells to the US. This brief note is to inform you of the Federal Register Notice titled “Human Cells, Tissues, and Cellular and Tissue-Based Product Establishments That Are Improperly Registered in the Electronic Human Cell and Tissue Establishment Registration System Due to Lack of Annual Registration Update” that published on June 1, 2023. This Notice of Intent can affect establishments located in Europe that are registered with us. FDA regulations require establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act and the regulations in 21 CFR part 1271 (“361 HCT/Ps”) to register and list their HCT/Ps with FDA’s Center for Biologics Evaluation and Research (CBER) using the electronic registration and listing system (21 CFR 1271.1(b), 1271.21, and 1271.22). Establishments that manufacture 361 HCT/Ps are also required to update their registration with FDA annually in December, even if there are no changes or updates to their information (§ 1271.21). The purpose of the Federal Register Notice is to announce FDA’s intention to begin inactivating the registration of HCT/P establishments that have not updated their registration during the annual update period, in accordance with FDA regulations, in the electronic human cell and tissue establishment registration system (eHCTERS). Email notification of the inactivation will be sent to the reporting official of the establishment, and the reporting official may access the establishment’s account in eHCTERS to change or update its registration. 5. Next Meetings of the National Competent Authorities We’ll speak again with all of you on 18 October 2023 (instead of 20 September) for the third virtual meeting of the blood, tissues & cells and organs competent authorities for 2023. We hope that you are enjoying or will enjoy soon a nice summer break. We remain available for further clarification on our personal email or at [email protected]. Best regards from 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 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Public Health, Cancer and Health security EU4HEALTH 2023 WORK PROGRAMME INFORMATION SESSION OPEN CALLS FOR ACTION GRANTS 30th June 2023, 10.00 – 16.10 CEST, Brussels time We invite you to join this webinar which will provide you further information about the open calls related to the EU4Health 2023 Work Programme. In particular the 2023 work programme will address health-related urgencies due to the COVID-19 pandemic and Russia’s unjustified and unprovoked war against Ukraine, it will support emerging policy initiatives by President von der Leyen in the State of the Union Address and in the associated Letter of Intent with a special attention on mental health, global health, the developments in digital health and medicinal products and it will address actions related to the recently adopted proposal for a Council recommendation on a new EU approach on cancer screening. The information session is organised by HaDEA with the participation of DG SANTE, DG HERA and DG ENER to present the policy context, objectives and expected impact as well as the procedure for this wave of open call. Register to this Information Session following this link. Once registered, you will receive the link and the registration ID to join the webinar on Thursday 30 June. This webinar will be held in English If you have any questions about the registration process, please contact sante- [email protected] We are looking forward to welcoming you online. The EU Health Policy Platform team European Commission Directorate-General for Health and Food Safety Unit B3 – Health monitoring and cooperation, Health networks Luxembourg The EU Health Policy Platform will host a live webinar organised by HaDEA, the European Health and Digital Executive Agency, on the 30th of June 2023, following this agenda: 10.00 – 10.05 Welcome Florina Telea, Head of Unit of EU4Health, Unit A.1. – HaDEA 10.05 – 10.15 - EU4H-2023-PJ-01 — Call for proposals to support access to medical devices for cross border health threats (CP-g-23-13) Ana BURGOS-GUTIERREZ, Policy Officer, DG HERA 10.15 – 10.25 - EU4H-2023-PJ-02 — Call for proposals to support stakeholders on the prevention of NCDs in the area of chronic respiratory diseases (DP-g-23-31-02) Yvette AZZOPARDI, Policy Officer, DG SANTE 10.25 – 10.35 - EU4H-2023-PJ-03 — Call for proposals on the prevention of NCDs in the area of mental health including actions supporting vulnerable population groups, such as migrants, refugees, Roma people and displaced people from Ukraine (DP-g-23-32-02) Yvette AZZOPARDI, Policy Officer, DG SANTE 10.35 – 10.45 - EU4H-2023-PJ-04 — Call for proposals on prevention of NCDs around dementia and other neurological disorders (DP-g-23-33-02) Yvette AZZOPARDI, Policy Officer, DG SANTE 10.45 – 10.55 - EU4H-2023-PJ-05 — Call for proposals to support the implementation of the agenda for medical ionising radiation applications (SAMIRA) – organisation of clinical audit campaigns as a tool to improve quality and safety of medical applications of ionising radiation (CR-g-23-44-01) Sophie PAULTRE, Policy Officer, DG ENER 10.55 – 11.05 - EU4H-2023-PJ-12 — Call for proposal: action grants to contribute to the organisations of conference and events (OA-g- 23-89) Adrian PERES, Deputy Head of Unit, DG SANTE 2 11.05 – 11.25 Questions and answers 11.25 – 11.35 Break 11.35 – 11.45 - EU4H-2023-PJ-06 — Call for proposals: action grants on mental health challenges for cancer patients and survivors Sub- topic (a): Mental health and Cancer (CR-g-23-19.01) Yvette AZZOPARDI, Policy Officer, DG SANTE 11.45 – 11.55 - EU4H-2023-PJ-07 — Call for proposals: action grants on mental health challenges for cancer patients and survivors Sub- topic (b): European Code for Mental Health (CR-g-23-19.02) Yvette AZZOPARDI, Policy Officer, DG SANTE 11.55 – 12.05 - EU4H-2023-PJ-08 — Call for proposals: action grants on the safety and quality of new Substances of Human Origin (Breast milk, faecal microbiota transplants) (a) (HS-g-23-50.01) Stefaan VAN-DER-SPIEGEL, Team Leader, DG SANTE 12.05 – 12.15 - EU4H-2023-PJ-09 — Call for proposals: action grants on the safety and quality of new Substances of Human Origin (Breast milk, faecal microbiota transplants) (b) (HS-g-23-50.02) Stefaan VAN-DER-SPIEGEL, Team Leader, DG SANTE 12.15 – 12.25 - EU4H-2023-PJ-10 — Call for Proposals: action grants on Facilitating Organ Paired Exchange (HS-g-23-51) Beatrice MARQUEZ-GARRIDO, Policy Officer, DG SANTE 12.25 – 12.35 - EU4H-2023-PJ-11 — Call for proposals for a program on orphan medical devices, in particular targeting paediatric patients (HS-g-23-65) Peter BISCHOFF-EVERDING, Legal Officer, DG SANTE 12.35 – 13.00 Questions and answers 13.00 – 14.00 Lunch 3 14.00 – 14.45 Administrative aspects of action grants - including Questions and Answers Marilena Di Stasi, Head of Sector, HaDEA 14.45 – 15.30 Financial aspects of action grants - including Questions and Answers Klara Kasnyik, Head of Sector, HaDEA 15.30 – 16.00 Questions and Answers 16.00 – 16.10 Wrap up of the info session Florina Telea, Head of Unit of EU4Health, HADEA Please be informed that this live webinar will be recorded. 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