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WP n.º

5

Title

Generic Good Practices for demonstrating safety and quality through recipient follow-up

Short description 

Competent Authorities of Tissues and Cells and of Blood are faced more and more with the evaluation of new processing technologies and novel products. There is a need to establish specific Quality and Safety requirements that should be applied by tissue establishments when developing those novelties. In addition, specific safety and efficacy criteria for the follow up of patients should be defined as well.

Specific objectives

• To define the threshold of novelty, including the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed
• To establish general parameters, criteria and methodologies for assessing and verifying the quality and safety of therapies with human tissues and cells through recipient follow-up

Expected outcomes

Definition of principles and methodologies for short and long term clinical follow up of recipients of blood, tissues and cells that have been prepared with newly developed and validated processes. 

How the work will be carried out

There will be four technical meetings with all the WP5 Part B participants and invited experts. This will allow a fruitful face to face discussions and the agreement on how to develop the deliverable about the principles. In between the meetings, working papers and the progressing draft documents will be circulated for comments. 

WP Leader

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