The aim of SOHOV&S is to support EU MS in the establishment of Vigilance and Surveillance(V&S)systems for tissues and cells in transplantation and in assisted reproduction. MS with most experience will facilitate less experienced in the implementation of systems. The guidance can be translated and used as basis for national procedures. The training will ensure that officials who have recently been given these responsibilities will quickly be able to fulfil them. The project will drive harmonisation in terminology, investigation approaches, facilitating communication and cross-border management of serious adverse events and reactions (SAR/E). WHO involvement will extend this outcome to a global scale. The training will provide EU investigators to react effectively and efficiently to SAR/E. The guidelines for clinical users will support MS in the efforts to inform clinicians of roles and responsibilities in relation to V&S. Awareness on V&S will be raised via the project website and the enhancement of the Eurocet platform to include data on V&S activities.
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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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The project aims to improve the safety of unrelated haematopoietic stem cell transplantation (HSCT), optimise HSC donation policy, and promote equal access to this therapy throughout the European Union.
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The project aims to develop Good Tissue Practices (Euro-GTPs Guide) and Personnel Training Guidelines for Tissue Establishments (TE) regarding recovery, processing and preservation of tissues, in order to ensure that all TEs guarantee the highest level of quality and safety of tissues for transplant.
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