Outcomes

1.       Euro-GTP II Guide will comprehend 4 major chapters/sections:

·  Generic requirements for demonstrating safety and quality (general standard principles and methodologies, common to all types of Tissues and Cells, which should be used to provide sufficient clinical validation data and follow-up data for the use safe of tissues/cells products/therapies.)

· Good Practices for demonstrating safety and quality through recipient follow-up Tissues – (specific criteria and parameters considered essential for the implementation of tissues preparation processes and/or novel clinical applications)

· Good Practices for demonstrating safety and quality through recipient follow-up – HSC (specific criteria and parameters considered essential for the implementation of HSC ‘products’, preparation processes and/or novel clinical applications)

· Good Practices for demonstrating safety and quality through recipient follow-up – ART (Determine specific criteria and parameters considered essential for the implementation of ART ‘products’ and/or novel clinical applications).

This guide will be a reference when TE/ORHAs need to plan their activities according methodologies and criteria defined as good practices.

2.     T&C database of tissues/cells products, processes, therapies, their current authorisation and implementation status and relevant biovigilance data associated.

3.   The Interactive Assessment Tool will be developed based on the outcomes defined in the Euro-GTP II Guide, and it will provide 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.

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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