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WP n.º

6

Title

Good practices for demonstrating safety & quality through recipient follow-up in Tissue

Short description 

The WP6 aims to determine specific criteria and parameters considered essential for the implementation of tissues/preparation processes and/or clinical applications, based on generic Good Practices proposed by the WP5.

The work will be developed by tissue bankers and experts from ORHAs, considering the regulation principles and ensuring the alignment of the proposed methodologies with the activities developed by Tissue Establishments (TEs), European standards and regulation.

Moreover, the WP6 participants will proceed with the identification of tissue ‘products’, preparation processes, clinical applications and patient follow-up programs and their respective status of validation and authorisation, therefore contributing for the T&C Database production (to be developed in collaboration with WP9)

Specific objectives

 

  • To establish the specific criteria and parameters considered essential to assess the quality and safety of tissue products/therapies and patient outcomes;
  • To identify the risk factors associated with the application of human tissue;
  • To determine study methodologies for the efficient evaluation of the human tissues, (ocular, skin, musculoskeletal, cardiovascular and amniotic membrane);
  • To contribute on the elaboration of the T&C Database, trough the Identification of tissues, preparation processes and patient follow-up programs already established. 

 

Expected outcomes

The outcomes of WP6 will be integrated by WP4 and WP9 to produce the EuroGTP II Guide, T&C Database, and the Interactive Assessment Tool.

WP6 will determine the 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

How the work will be carried out

The work will be carried out in close collaboration with experts from TEs and ORHAs, and the inputs of the collaborating scientific associations, hence the endorsement of stakeholders is considered crucial for the future recognition and utility of the developed tools.

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