European Projects

EU JOINT ACTION GAPP-PRO (ongoing)
GAPP-PRO – Piloting Gapp model approach for assessing and authorizing novel substances of human origin preparation process.” The European Joint Action, in which the Istituto Superiore di Sanità participated as coordinator through CNS and the National Transplantation Center (NTC), aims to test and refine the methodology of the previous JA GAPP with the goal of:

• Simulate the authorization processes for new products in the different areas of activity of the donation and transplantation of substances of human origin (e.g. transplantation of microbiota, breast milk, eye drops, etc.);
• Verify the ability to implement the model in different member states, with particular reference to a common assessment of risk levels;
• Test the methodology from a multi-country assessment perspective;
• Training assessors;
• Test the feasibility of putting joint assessments in place including through the involvement of stakeholders from the medical device and advanced therapies sectors.

EU SERVICE SIGHTSoHO (in progress),
SIGHTSoHO – Strengthening overSIGHT through training and networking on Substances of Human Origin.The European agency HaDEA has awarded the National Blood and Transplant Centers the contract for the Training and networking of Substances of Human Origin (SoHO) Competent Authorities’ staff for oversight service with the aim of improving the implementation of European legislation on blood and blood components, tissues and cells, and organs and to strengthen cooperation between national competent authorities and industry associations. CNS and CNT, in collaboration with platform provider Zadig Ltd and technical tutors (internal CNS/CNT staff, external staff from other EU competent authorities), developed a distance and in-person training program targeting staff of national competent authorities for substances of human origin SoHO (inspectors, assessors, and biovigilance officers). The main outcome will be the improvement and standardization of the competencies of the sector target groups identified at the European level. In addition, the initiative aims to build a network of senior inspectors/assessors in order to facilitate possible joint inspections and assessments, as well as enhance Audits between Member States thus strengthening trust between them and increasing the exchange of SoHO. For information:

www.sightsoho.eu

EU JOINT ACTION CHESSMEN (in progress)
CHESSMEN – Coordination and Harmonization of the Existing Systems against Shortage of Medicine – European Network

It is a European joint action coordinated by AIFA, with the support of the National Blood and Transplant Centers. The main objective is to address the problem of drug shortages by developing and proposing prevention strategies and ad hoc mitigation measures to member states through a careful analysis of good practices and know-how disseminated at the national level. CHESSMEN involves 27 partners from 22 European countries. For information:

www.ja-chessmen.eu
Chessmen Leaflet

EU PROJECT SUPPLY (in progress)
SUPPLY – Strengthening voluntary non-remunerated plasma collection capacity in Europe

It is a project co-funded by the European Union’s EU4Health program to increase plasma collection from unpaid voluntary donors across Europe. The 18-month project will produce guidelines and best practices that can be used by transfusion services across Europe to boost plasma collection and ensure adequate levels of production of plasma-derived medicines, life-saving drugs whose clinical applications are increasingly widespread. The project involves the National Blood Center , as leader of a technical package, and 19 other partners (14 grantees and 6 associates) from 14 European countries and coordinated by the EBA – European Blood Alliance, the association representing blood banks and transfusion authorities, at the European level. For information:

supply-project.eu
LinkedIn

EU PROJECT EGALiTE (in progress)
EGALiTE – European Group for Accreditation and Liaison of Blood-Tissues and Cells Establishments

It is a project embedded within the European Union’s EU4Health program, established in response to the emergency induced by the Covid-19 pandemic with the aim of strengthening the resilience of health systems. The project, which involves 10 countries and 15 partner entities, including the National Blood Center and the National Transplant Center, aims to promote harmonization in the accreditation of organizations that manage substances of human origin such as blood, tissues, cells and organs ensuring access to safe and high-quality therapies, particularly in times of crisis. EGALiTE in 30 months will achieve specific goals: establish a European accreditation program, develop a database of resources for planning support in organizations, including to foster collaboration between professionals and competent authorities, provide contingency planning, and establish a technical assistance program to implement best practices and optimize activities in different member states. For information:

www.egalite-europe.eu
EGALiTE flyer
EGALiTE leaflet

EU JOINT ACTION GAPP (concluded)
GAPP – facilitatinG the Authorisation of Preparation Process for blood and tissues and cells

It is the European Joint Action, in which the Istituto Superiore di Sanità participated as coordinator through CNS and CNT, aimed to develop an optimal and common European approach to the evaluation and authorization of new processes for the preparation of human blood, tissues, and cells for transplantation purposes. The GAPP project involved 18 countries. The Joint Action lasted 36 months and ended in January 2022. Outputs from the initiative helped guide the European Commission in developing the proposal for a new European regulation on substances of human origin, which is hopefully expected to be approved by the end of 2024. For information:

www.gapp-ja.eu
GAPP Promotional Video