The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aim to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.
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GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.
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The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantation. 7 core work-packages (WP) have been defined. WP4 will explore commonalities between vigilance reporting in these fields, identifying opportunities for harmonising procedures. WP5 will increase the sharing of vigilance information of didactic value in order to achieve higher standards of quality and safety across blood, tissues and cells, as well as defining regulatory principles for short and long term follow up of recipients of blood, tissues and cells that have been prepared with newly developed and validated processes. WP6 will focus on the development of common Inspection Guidelines for EU Competent Authorities responsible for the inspection and authorization of blood and tissue establishments. The main objective is the identification of a common framework for the conduct of inspections of blood and tissue establishments, developing a common approach with sharing of procedures across MS. The educational profile, basic competencies and specific skills required by MS for the respective inspectors in these fields will be defined in WP7. This action will include a number of initiatives aimed at increasing the interaction between inspectors from different MS including inspector training, a framework for joint inspections by multi-MS teams (WP8), a pilot for regional inspections and the creation of an inter-MS (WP9) inspection system auditing programme. The impact of these activities will be greatly increased by virtue of their conduct across the fields of blood, tissues and cells and ART. Greater inter-MS circulation of tissues and cells will also be facilitated by this action through support for the harmonised implementation of the Single European Code (WP10) and its associated compendia of tissue establishments and tissue and cell products.
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