GAPP

GAPP

FacilitatinG the Authorisation of Preparation Processes for blood, tissues and cells

Financed by : European Commission

Program : 3rd HEALTH PROGRAM – CALL FOR PROPOSALS FOR PROJECTS 2016

Grant Agreement ID: 785269 

Role in the project: Coordinator

Duration: May 2018 to May 2021

Contact: Ponce, Laura

ABSTRACT

GAPP Joint Action is aiming at facilitating the development of a common and optimal approach to assess and authorize preparation processes in blood and tissues establishments (BEs and TEs), adapting requirements as prescribed by Article 29 of Directive 2002/98/EC and Article 28 of Directive 2004/23/EC .

Since the directives for these fields were adopted, significant technical developments have taken place and the complexity of preparation processes has greatly increased. Increasing complexity of processing can bring significant quality and functionality improvements for patients, and/or more efficient use of donations, but it can also bring increased risk, particularly as the level of complexity brings the final product towards the borderline with medicinal products.

GAPP will ensure that any possible advantage or outcome is taken into account from two ongoing Public Health Programme projects focused on tissues and cells (EuroGTP and ECCTR) incorporating a need for clinical follow-up data as part of a comprehensive process authorization.GAPP durable output is that a knowledge sharing platform on PPAs will be developed and fed in order to facilitate sharing of information among European Union, Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorize preparation processes of tissues, cells, reproductive cells and blood products.

GAPP objectives are:
1) increasing consistency and efficacy of competent authority regulatory activities through harmonization of EU-level tools for authorization procedures for preparation processes at blood and tissues establishments
2) developing a concept model for a European knowledge-sharing platform that can support CAs in the assessment and evaluation of novel preparation processes of products
3) developing an international network of experts that can support CAs in the assessment and evaluation of preparation processes of products, trained by the Joint Action”

PARTNERS

  • ISTITUTO SUPERIORE DI SANITA (Coordinator)
  • GENIKO PERIFERIAKO NOSOKOMEIO PAPAGEORGIOU
  • DIOIKHSH YGEIONOMIKHS PERIPHEREIAS KRHTHS
  • NATIONAL REGISTRY TO THE VOLUNTARY DONATOR OF CELULE STEM HEMATOPOIETICE
  • MINISTARSTVO ZDRAVLJA REPUBLIKE HRVATSKE
  • Health and Social Care Inspectorate
  • HEALTH PRODUCTS REGULATORY AUTHORITY
  • SERVEI CATALA DE LA SALUT
  • VIESOJI ISTIAGA NACIONALINIS KRAUJO CENTRAS
  • MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
  • Agence of biomedical
  • LAAKEALAN TURVALLISUUS-JA KEHITTAMISKESKUS
  • BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
  • BANC DE SANG I TEIXITS

·        KRAJOWE CENTRUM BANKOWANIA TKANEK I KOMOREK

·        HUMAN TISSUE AUTHORITY

·        AGENTIA DE TRANSPLANT

·        EXECUTIVE AGENCY FOR TRANSPLANTATIO

·        EXECUTIVE AGENCY ‘MEDICAL SUPERVISION

·        Ministry of Health of the Republic of Cyprus

·        Medical Products Agency

·        ASOCIACION ESPAÑOLA DE BANCOS DE TEJIDOS

·        SERVICIO ANDALUZ DE SALUD

·        LIETUVOS SVEIKATOS MOKSLU UNIVERSITETO LIGONINE KAUNO KLINIKOS

·        FONDAZIONE IRCCS CA’ GRANDA – OSPEDALE MAGGIORE POLICLINICO

·        MINISTRY OF HUMAN CAPACITIES

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