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Saatja: <[email protected]> Saadetud: 05.09.2022 17:38 Adressaat: <[email protected]>; <[email protected]> Koopia: <[email protected]> Teema: Reminder: SUPPLY PROJECT: Kick-off meeting and CAs meeting Dear all, This is a reminder sent on behalf of the SUPPLY project coordinator to register to the SUPPLY Competent Authorities meeting that will be held in hybrid format (in person and online) on 27 September 2022. See below and attached for more details. The deadline was on 29 August 2022, however the coordinator is willing to accept last minute registrations, please do not delay further. Best regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit B4 Medical Products: quality, safety, innovationOffice address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium Dear Competent Authorities for Blood and Blood Components, The SUPPLY Project Strengthening voluntary non-remunerated plasma collection capacity in Europe, led by EBA, will start on September 1. Given the significant role you as Competent Authorities play in the plasma value chain, on behalf of the Coordinator we are writing to invite you to the SUPPLY Competent Authorities meeting that will be held in hybrid format (in person and online) on September 27. The project Consortium is keen to discuss your present concerns and future expectations for the plasma value chain, as well as how the SUPPLY project can contribute to filling any identified gaps and ensure the appropriateness and usability of the final recommendations. We also look forward to discussing the new proposed EC SoHO Regulation and how best to align the SUPPLY project. Please find herewith attached the event Announcement, including registration link and agenda as well as some practical information. Deadline to register is August 29. Also on behalf of the Coordinator, many thanks once again for your support! Kind regards, Livia Amsterdam, 25 July 2022 Subject: Competent Authorities meeting SUPPLY Project Dear Competent Authorities, We have the pleasure to invite you to nominate one Competent Authorities representative from your country to attend the SUPPLY meeting-off meeting with the Competent Authorities, which will be held on September 27th in Amsterdam. You are kindly requested to arrange your journey and we will reimburse one person per organization for the following maximum amount: accommodation up to 133 Euros/night for accommodation, travel up to 400 Euros and subsistence 103 Euros. All the receipts (namely: travel tickets, boarding passes, hotel receipts) and duly completed reimbursement form, must be sent after the meeting to: Peter O’Leary European Blood Alliance C/o BLSI, Clos Chapelle-aux-Champs, 30 B-1200 Brussels, Belgium We are looking forward to receiving your answer. Thank you in advance for your collaboration. Best Regards, SUPPLY’s Coordinator Peter O’Leary Executive Director, European Blood Alliance SUPPLY Hybrid Kick-Off Meeting addressed to national competent authorities 27 September 2022 RATIONALE Achieving a sufficient level of strategic independence in plasma for fractionation is a key factor in sustaining the long-term supply of plasma derived medicinal products (PDMPs) needed by patients in Europe. The SUPPLY project, led by the European Blood Alliance, represents a significant investment of €1.889Million towards making the EU more strategically independent in its need for plasma medicines, with the European Commission providing the SUPPLY project with a grant of €1.133Million through the EU4Health programme and €0.756Million coming from the project consortium members, including not-for-profit blood establishments. The SUPPLY project will be carried out by a large European consortium with broad and complementary expertise in all aspects of blood and plasma collection, processing and medicinal use and will assess the current legal frameworks and policies in the EU on plasma collection and procurement models to facilitate this process. The main outcome of the project is a set of recommendations and guidelines for not-for-profit blood establishment competent authorities, medical societies, and other professional stakeholders to help them grow plasma collection and to achieve a resilient supply in the EU. ORGANISATIONAL DETAILS The meeting will be held on September 27, at Auditorium Plesmanlaan 125 Amsterdam (Sanquin), with the possibility to attend either in person or online. The event is now open for registration. By registering in this link, you are kindly invited to state if you attend residentially or remotely. Please, register within August 29, 2022. In case you will be joining in person, we would like to inform you that the European Blood Alliance will reimburse the travel and hotel expenses for attendance at the meeting, we kindly ask that only one Competent Authority representative be present in person for these reimbursements. If you have any questions, feel free to contact the European Blood Alliance at [email protected] ABSTRACT OF THE PROJECT The Covid-19 crisis has shown how vulnerable the world is in supply of life-saving medicines. Plasma-derived medicines, particularly immunoglobulins, today face shortages in Europe. Simultaneously, there is an imbalance in the global collection of plasma needed for the products, with a high dependence of plasma coming from the U.S. The SUPPLY project therefore aims to increase and strengthen the resilience of plasma collection in the EU to enable a stable and adequate supply of medicines in Europe. A substantial part of plasma collection in the EU is conducted by the non-profit blood establishments (BEs) from voluntary non- remunerated donors, but not at the level needed. This project will focus on how BEs can improve and build up voluntary non-remunerated plasma collection programs and make them more efficient. Emphasis will be paid to maintaining donor safety in a way that benefits donor health and plasma quality intended for production of medicinal products. The project will evaluate current legal frameworks and policies in the EU on plasma collection and tender models to facilitate this process. Since plasma demand comes from the use of immunoglobulins, it is vital that its use is appropriate, and prioritisation is properly guided. The SUPPLY project, led by the European Blood Alliance, will be carried out by a large European consortium with broad and complementary expertise relating to all aspects in blood and plasma collection, processing, and medicinal use. The main project outcome is a set of recommendations and guidance for BEs, competent authorities, medical societies, and other professional stakeholders to support them in being able to increase plasma collection in the EU by the public health sector and achieve optimal availability of plasma medicines for patients both in a general situation as well as in times of crises. This project will therefore contribute to the EU becoming more strategically independent in its need for plasma medicines. DRAFT PROGRAMME 09.00 Arrival and Registration 09.30 Welcome address and introduction to SUPPLY Project Daphne Thijssen-Timmer, SUPPLY Project Leader, Director, Sanquin Blood Bank, Interim CEO Peter O’Leary, SUPPLY Project Coordinator, Executive Director, European Blood Alliance 10.00 The proposed EC SoHO Regulation and the SUPPLY project SoHO Team, to be confirmed 10.20 WP Overview and Impact WP Leaders 11.10 Q&A 11.30 Break 11.40 WP4 Survey Vincenzo de Angelis 12.00 Q&A 12.10 Take home message and next steps Daphne Thijssen-Timmer 12.20 End of the meeting