Partners

About

Partners

Coordinator

Istituto Superiore di Sanità (ISS – CNT – CNS), Italy

The National Institute of Health (ISS) is a public technical and scientific body of the Italian NHS, under the control of the Ministry of Health (MoH). It hosts CNT and CNS. The Italian National Transplant Centre (CNT) is a technical body of the Ministry of Health, it was set up under the Law n. 91 of 1999 and it is located at the ISS where it performs its activities as a department of the same body. CNT coordinates all activities regarding donation, allocation and transplantation of organs as well as donation, banking and transplantation of tissues, in particular it lays down protocols for quality and safety and is together with Regional authorities the CA for implementing EU in-the-field Directives. The Italian National Blood Centre (CNS) is entrusted, by the national law, to support the scientific research in the field of transfusion medicine with the aim to assess the suitability, the effectiveness and the sustainability of innovative processes or processes based on innovative technologies having a potential impact on the clinical outcome of patients receiving blood and blood components.

http://www.iss.it

 

Associated Partners

PAPAGEORGIOU General Hospital of Thessaloniki (GHP), Greece

 

The Papageorgiou General Hospital of Thessaloniki is a Legal Entity Governed by Private Law, of a non-profit nature, which offers prevention, diagnosis, treatment and rehabilitation services.

It is a hospital with functionality and high designing and technological standards, a modern building at the NW side of Thessaloniki at the area of N. Efkarpia in the Municipality of Pavlos Melas, next to the ring road, and 7km from the city center. It consists of buildings that cover an area of 75,000 m2 inside a lot of an area of 150,000 m2.

 

The 7th Health Region Crete (HC - Crete), Greece

 

It is the tactician vector control and  management of the National Health System at the Region of Crete.

https://www.hc-crete.gr/

 

National Registry of Hematopoietic Stem Cells Voluntary Donors, Romania

 

The National Registry of Hematopoietic Stem Cells Voluntary Donors is the institution responsible for the coordination and survaillance of all activities regarding the recruitment, testing and hematopoietic stem cells donation from unrelated donors, according to the standards of World Marrow Donors Association.

http://www.rndvcsh.ro

 

Ministry of Health of the Republic of Croatia (MoH HR), Croatia

Ministarstvo zdravstva

Ministarstvo zdravstva

 

Ministry of Health of  the Republic of Croatia (MOH RC) is Competent Authority for the field of SOHO (blood,  tissues, cells, ART, organs) and is in charge of SOHO inspection. Service for Blood, Tissues and  Cells Inspection have been actively involved in various projects: pre-accession and post- accession projects that continued with TAIEX out and Twinning out projects; EU Health  Programme - Joint action projects (ARTHIQS and VISTART), as well as participation in  development of EDQM Guide for the quality and safety of Tissues and Cells for human  application (2nd and 3rd Edition).  

https://zdravlje.gov.hr/

The Health and Social Care Inspectorate (IVO), Sweden

 

It is the Governmental Agency for  supervision of health and social care in Sweden and a CA for Blood, Tissues and Cells (T&E)  and organs. As such IVO is responsible for authorization, supervision (including inspection) and  vigilance in the area of Blood, T&E and organs. Three national coordinators located in East dept.  (Stockholm) are coordinating and leading the overall supervision and inspections are performed  together with one regional inspector.  

https://www.ivo.se/om-ivo/other-languages/english/

 

Health Products Regulatory Authority (HPRA), Ireland

 

It is responsible for regulating a  wide range of health products available in Ireland. This includes human and veterinary  medicines, medical devices, blood components and human tissues and cells. HPRA regulates  manufacturing, wholesale and distribution companies, medical device notified bodies as well as  other health product facilities.  The role of HPRA involves regulating other related areas  including clinical trials and human organs for transplantation, to monitor the safety of cosmetics,  to license and monitor the use of animals for scientific or educational purposes, ensuring that the  3R principles (replacement, reduction and refinement) are applied.

https://www.hpra.ie/

 

Organización Catalana de Trasplantes (OCATT), Spain

 

It is the organization responsible  for planning ordering and coordinating activities related to the extraction, preservation,  distribution, transplant and interchange of organs, tissues and cells for their use to therapeutic  ends in Catalonia. OCATT depends on the Health Department of the Government of Catalonia. 

http://trasplantaments.gencat.cat/ca/ocatt/

 

Medicines & Healthcare products Regulatory Agency (MHRA), UK

 

The MHRA has  been the UK competent authority under the EU Blood Directive since 2005 and prior to the  introduction of this EU legislation had been responsible for the supervision and inspection of  blood collection and processing sites in the UK since the 1980s. The MHRA is also the UK  competent authority for medicinal products.

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

 

Agence de la Biomédicine (ABM), France

 

The Agence de la biomédecine is the French  competent authority for organ, tissue and cell transplantation, assisted reproductive technology, human genetics and embryo and stem cell research. It advises on inspection and licensing and is  responsible for vigilance in its fields.

https://www.agence-biomedecine.fr/

 

Laakealan Turvallisuus-JA Kehittamiskeskuss (FIMEA), Finland

 

Fimea is a  competent authority (CA) in Finland on the field of cell, tissue and blood establishment  supervision, and it is responsible of inspections and licensing of cell, tissue and blood  establishments. Fimea is also responsible of controlling medicines (CA) and narcotics in Finland  and is working under the aegis of the Ministry for Social Affairs and Health.

http://www.fimea.fi/

 

Paul Ehrlich Institut (PEI), Germany

 

The Paul-Ehrlich-Institut (PEI), the Federal Institute for  Vaccines and Biomedicines in Germany, is a senior federal authority in the field of medicinal  products providing services in public health. The PEI assesses and monitors the benefit-risk  balance before, during and after the marketing authorisation of biomedicines for human use  including blood, tissues and cells, and immunological medicines for veterinary use. The PEI’s  own experimental research in the field of life sciences is an indispensable basis for the fulfilment  its duties. The PEI reports to the German Federal Ministry of Health. 

https://www.pei.de/DE/home/de-node.html

 

Banc de sang i teixits (BST), Spain

 

The Banc de Sang I Teixits (BST) is a public agency of  the Catalan Department of Health whose mission is to guarantee the supply and proper use of  human blood and tissues in Catalonia. 

BST’s staff expertise is internationally recognized, the organization is also involved as  coordinator and associative partners of several EU projects namely: EuroGTP II (Coordinators),  VISTART (external evaluator), DoHeCa (Associative Partners) Euro-GTP (Coordinators),  European Quality System for Tissue Banking (EQSTB) (Coordinators), and V&S SoHO  (collaborative partners), etc. 

https://www.bancsang.net/

 

Krajowe Centrum Bankowania Tkanek I Komorek (KCBTiK), Poland

 

KCBTiK is a  budgetary unit submitted to the Polish Ministry of Health. KCBTiK tasks include i.a. supervision  and inspection of T&CB and organizing the trainings (recovery, collection, testing, processing,  sterilization, storage and distribution of cells and tissues). KCBTiK is/was a beneficiary of many  Programmes / Joint Actions incl. EQSBT, EUSTITE (WP Leader), Euro-GTP (WP Leader),  SOHOV&S, ARTHIQS, VISTART, Euro-GTPII (WP Leader)

http://www.kcbtik.pl/

 

Human Tissue Authority (HTA), UK

 

The HTA has extensive experience in the  authorization of novel preparation processes across a wide range of tissue/cell-based products and  has implemented a range of governance systems to manage the authorisation process. Their  experience in this area, together with the work done on defining data requirements and criteria for  validations, will be of particular benefit WP 5 and 6.

https://www.hta.gov.uk/

 

Executive Agency for Transplantation (EAT), Bulgaria

 

Bulgarian Executive Agency of  transplantation is the competent authority for management, coordination and control of the  transplantations of organs, tissues and cells in Bulgaria. The organization is maintaining public  and official registers about the donors and potential recipients of organs tissues and cells. 

http://bgtransplant.bg/iat/index.php

 

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Istituto Superiore di Sanità (ISS – CNT – CNS), Italy

PAPAGEORGIOU General Hospital of Thessaloniki (GHP), Greece

The 7th Health Region Crete (HC - Crete), Greece

National Registry of Hematopoietic Stem Cells Voluntary Donors

Ministry of Health of the Republic of Croatia (MoH HR), Croatia

The Health and Social Care Inspectorate (IVO), Sweden

Health Products Regulatory Authority (HPRA), Ireland

Organización Catalana de Trasplantes (OCATT), Spain

Medicines & Healthcare products Regulatory Agency (MHRA), UK

Agence de la Biomédicine (ABM), France

Laakealan Turvallisuus-JA Kehittamiskeskuss (FIMEA), Finland

Paul Ehrlich Institut (PEI), Germany

Banc de sang i teixits (BST), Spain

Krajowe Centrum Bankowania Tkanek I Komorek (KCBTiK), Poland

Human Tissue Authority (HTA), UK

Agentia Transplant (AT), Moldova

Executive Agency for Transplantation (EAT), Bulgaria

Ministry of Health of the Republic of Cyprus (MHC), Cyprus

Läkemedelsverket (MPA), Sweden

Asociación Española de Bancos de tejidos (AEBT), Spain

Servicio andaluz de salut (SAS), Spain

Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos (HLUHSKKA), Lithuania

Vilniaus Universiteto Ligoninės Santariškių Klinikos (VHSK), Lithuania

Ministry of Health – Government of Malta (MHM), Malta

Fondazione IRCCS CA’Granda Ospedale Maggiore Policlinico (POLMI), Italy

Emberi Erőforrások Minisztérium (EEM), Hungary

Ministry of Health of the Republic of Cyprus (MHC), Cyprus

 

 The Cyprus Ministry of Health has  as a main responsibility the organization and provision of quality healthcare services and medical  treatment to the citizens. The Ministry is the Competent Authority for Blood and Blood  components and for cell & tissues. 

https://www.moh.gov.cy/moh/moh.nsf/index_en/index_en

 

Läkemedelsverket (MPA), Sweden

 

MPA is the Medical Products Agency of Sweden. The  organization has a huge experience in GMP applied to blood establishment, hospital pharmacy,  radiopharmaceuticals, GMP inspections and accreditation of tissue establishments 

https://lakemedelsverket.se/english/

 

Asociación Española de Bancos de tejidos (AEBT), Spain

 

The AEBT is a non-profit association  of scientific nature whose main objective is organising and promotingall the activities related to  the maintenance and transplantation of human cells, tissues and organs.

http://www.aebt.org/

 

Servicio andaluz de salut (SAS), Spain

 

Servicio Andaluz de Salud (Andalusian Health Service) is a  public body providing all healthcare services to the 8.4 million inhabitants in Andalusia, under  the control of the Andulasian MoH. Its mission is to provide high-quality public healthcare to the  citizens, ensuring its accessibility and the satisfaction of its users, and seeking efficiency and  optimum use of resources.

http://www.juntadeandalucia.es/servicioandaluzdesalud/principal/documentosAcc.asp?pagina=pie_contacto

 

Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos (HLUHSKKA), Lithuania

 

Lithuanian University Hospital of Health Sciences Kaunas Clinics is the biggest hospital in Lithuania, with a lot of experienced specialists. In Hemathology dept hematologists,  transfusiologists, biologists are working with blood and tissue products and have a special  expertise products preparation and related quality requirements.

http://www.kaunoklinikos.lt/kk/

 

Vilniaus Universiteto Ligoninės Santariškių Klinikos (VHSK), Lithuania

 

Vilnius University  Hospital, Santaros klinikos is a leading university hospital in the country.  Multidisciplinary approach and highly qualified specialist are ready to put their efforts  for cooperation in WP6 Joint action, especialy in fields of Haematopoetic stem cells.

http://santa.lt/

 

Ministry of Health – Government of Malta (MHM), Malta

 

The Competent Authority in Malta  falls under the responsibility of the Superintendence of Public Health within the Department for  Health Regulation. It is responsible for the inspections and licensing of tissues, cells, organs and  blood establishments. The Competent Authority will be participating in collaboration with the  National Medicines Authority.

http://deputyprimeminister.gov.mt/en/Pages/health.aspx

 

Fondazione IRCCS CA’Granda Ospedale Maggiore Policlinico (POLMI), Italy

 

Through a  joint decree of the Italian Ministry of Health and the Ministry of Education, the Fondazione  IRCCS Ospedale Maggiore Policlinico has been recognized “Scientific Institute for Research and  Health Care” (IRCCS) with the mission to foster health care through translational research. The  Foundation has a strong, consolidated expertise in the development and evaluation of innovative  diagnostic and therapeutic patterns, on the basis of the knowledge stemming from basic and  clinical research, as well as from biotechnological innovations.

http://www.policlinico.mi.it/

 

Emberi Erőforrások Minisztérium (EEM), Hungary

 

The Ministry of Human Capacities (Emberi  Erőforrások Minisztériuma) is the legal successor of the former National Public Health and  Medical Officer Service Office of the Chief Medical Officer (NPHMOS OCMO) regarding tissue  and cell authority. In the Ministry the Országos Tisztifőorvosi Feladatokért Felelős Helyettes  Államtitkárság (Deputy State Secretariat Responsible for Tasks of National Chief Medical  Officer) is the department responsible for the tasks of the former NPHMOS OCMO. 

Now it is the competent authority on tissues and cells, but not on blood and blood products. Its  competency covers the following in the whole country: authorisation of tissue and cell  establishments, assisted reproduction therapy (in vitro fertilisation) facilities; inspections in tissue  establishments; approving importing and exporting of tissues and cells; carrying out control  measures in case of serious adverse reactions or serious adverse events, keeping the required  registers of tissue establishments.

http://www.kormany.hu/en/ministry-of-human-resources

 

Agentia Transplant (AT), Moldova

 

It is the Moldovan competent authority in the field of  organ, tissue and cell transplantation and is responsible for carrying out national policies and  programs regarding the donation and transplantation of tissues and cells. It is functioning directly  under the Ministry of Health.

http://www.transplant.gov.md/

 

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