EURO-GTP II outcomes available

The Euro-GTP II aims 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 and evaluation. The outputs of the Euro-GTP II project will provide tools for assessing and verifying quality, promoting safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly the implementation of novel T&C preparation processes and clinical indications, but also the need for retrospective studies where weaknesses or insufficient safety data currently exist.

Some important outcomes of the European GTP II are available: the 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 and implement the result of risk assessment into routine practice and follow up the results.

In addition, the Interactive Assessment Tool (IAT provides an “algorithm” implemented in a user friendly online interface. This tool will be useful to implement, evaluate and authorize a novel T&C product, process or therapy.

The associated e-learning module aims: to improve the scientific assessment of novel products/processes/clinical indications and associated risks, and promote the correct definition of evaluation protocols to guarantee its safe implementation. Registration on the project webpage: http://www.goodtissuepractices.eu/index.php/2-uncategorised/55-e-learning