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Key Considerations:

The goal of this training is that participants learn to use the tools and methodologies in accordance with the rationale defined by the authors of the EuroGTP II project.

Thus, the course 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.




The generic objectives of this course are:

• To promote good practices for the correct implementation of novel BC and blood therapies.

Provide insight regarding the rationale behind EuroGTP II’s methodologies.

Support the appropriate use of tools and methodologies provided by the EuroGTP II Project, and the correct interpretation of its outcomes.




By the end of this training participants should be able:

Correctly assess the novelty of a BC or blood therapy.

Understand the different risk factors and risk consequences associated with the Blood Establishments (BE) activities and clinical application of BC.

Perform objective risk analysis based on the rationale proposed by EuroGTP II – by evaluating the risks resulting from all aspects of Blood Component, Tissues and Cells (BTC) supply chain (from donor selection to clinical application).

Design appropriate studies proportionate to the level of residual/unknown risk to confirm that the BTC is safe and effective.




The targets of this training are:

Blood Establishments’ (BE) professionals: operational staff, scientists and quality control personnel.

• Health care professionals: namely the end users of novel BTC.

Competent Authorities (CAs): officer who wish to obtain a better insight regarding the use and interpretation of results provided by the EuroGTP II methodologies


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