Objectives

EuroGTP II aims to:

·  Develop common Good Practices for European Tissue Establishments (TE) and Organisations Responsible for Human Application (ORHAs), that address the studies extent (retrospective, concurrent, prospective and short and long term) needed for human application of the tissues/cells in a safe and effective manner:

                a.        Determining methodologies for assessing the risks associated to novel tissues/cells;

                b.        Determining methodologies for assessing the extent of the studies needed to provide enough quality, safety and efficacy data for the use of tissues/cells;

                c.         Determining the follow up programs, according to the inputs of the previous issues, to ensure safety and support the evaluation of the clinical efficacy

 

·   Develop a database of products, preparation procedures, clinical applications and follow-up programs, and their current status of authorisation and implementation (established/validated; validation studies in progress; discarded for clinical application);

·   Propose a GTP’s Management Model foreseeing future update, promotion and harmonization of GTP’s standards, and the implementation of accreditation and training programmes at European level.

 

 

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