EuroGTP II Campus: https://tissues.courses/
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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.
Objectives
The generic objectives of this course are:
- To promote good practices for the correct implementation of novel Tissue and Cells Therapies and Products (TCTP).
- 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.
Competences
By the end of this training participants should be able:
- Correctly assess the novelty of a TCTP.
- Understand the different risk factors and risk consequences associated with the TE’s activities and clinical application of Substances of Human Origin.
- Perform objective risk analysis based on the rationale proposed by EuroGTP II – by evaluating the risks resulting from all aspects of T&C supply chain (from donor selection to clinical application) of the final product.
- Design appropriate studies proportionate to the level of residual/unknown risk to confirm that the TCTP is safe and effective.
- Understand the value of the Tissue & Cell Database.
Targets
The targets of this training are:
- Tissue Establishments’ (TE) professionals: operational staff, scientists and embryologist developing TCTPs, quality control personnel.
- Health care professionals: namely the end users of novel TCTPs.
- Competent Authorities (CAs): officer who wish to obtain a better insight regarding the use and interpretation of results provided by the EuroGTP II methodologies
