Outcomes

 

1.   Euro-GTP II Guide provides structured guidance on how to use the tools and methodologies developed by the EuroGTP II project, namely the use of systematic, risk-based mechanism to:

·         Evaluate if a new or changed TCTP has significant novelty

·         Determine the overall risk arising from the novelty

·         Determine an appropriate level of pre-clinical and clinical evaluations to address and assess the risk

·         Implement the result of risk assessment into routine practice and follow up the results

                                                                     

 

2.   The Interactive Assessment Tool was developed based on the outcomes defined in the Euro-GTP II Guide, and provides information related with procedures, protocols and clinical data required to ensure quality and safety. 

The Interactive Assessment Tool will consist in an “algorithm” implemented in a user friendly interface that should became available on-line, and could be used by TE professionals and NCAs for practical assessment of extended studies and follow-up programs needed to implement, evaluate and authorise a novel T&C product, process or therapy.

                                                                            

 

3.  Tissue & Cells Database of products, processes, therapies, their current authorisation and implementation status and relevant biovigilance data associated.(Watch the tutorial video to learn how you can introduce and publish your data) 

                                                                           

 

4.  GTP´s management model will propose a structure for the development of European accreditation and training programmes for TEs and ORHAs, inspired on models already implemented by relevant scientific societies in the field, which have successfully demonstrated that accreditation programmes are viable, and efficient promoting quality and safety standards amongst countries.

 

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