About

facilitatinG the Authorisation of Preparation Process for blood and tissues and cells (GAPP)
This newly started project deals with a review of regulatory and technical standards for innovation in the field of blood, tissue and cell products. GAPP will lean on the EuroGTP II and VISTART projects and will establish bridges with the tools developed by professionals in the EuroGTP II project.

The project aims at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissue establishments with particular attention devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. The final aim is to increase harmonisation of those member states (MS) activities that regulate the areas of blood transfusion, transplantation of tissues and cells and ART.
Special attention is given to the field of ART that involves a considerable amount of movement of both donated substances of human origin and citizens between MS. The Joint Action will prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” with three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three parts, namely blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing; iii) assessing clinical data. Finally, a tool will be built to facilitate sharing of information among EU Competent Authorities (CA), and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.

Start date: 01/05/2018 - End date: 30/04/2021