GAPP Joint Action is aiming at facilitating the development of a common and optimal approach to assess and authorize preparation processes in blood and tissues establishments (BEs and TEs), adapting requirements as prescribed by Article 29 of Directive 2002/98/EC and Article 28 of Directive 2004/23/EC .
Since the directives for these fields were adopted, significant technical developments have taken place and the complexity of preparation processes has greatly increased. Increasing complexity of processing can bring significant quality and functionality improvements for patients, and/or more efficient use of donations, but it can also bring increased risk, particularly as the level of complexity brings the final product towards the borderline with medicinal products.
GAPP will ensure that any possible advantage or outcome is taken into account from two ongoing Public Health Programme projects focused on tissues and cells (EuroGTP and ECCTR) incorporating a need for clinical follow-up data as part of a comprehensive process authorization.
GAPP durable output is that a knowledge sharing platform on PPAs will be developed and fed in order to facilitate sharing of information among European Union, Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorize preparation processes of tissues, cells, reproductive cells and blood products.
GAPP objectives are:
1) increasing consistency and efficacy of competent authority regulatory activities through harmonization of EU-level tools for authorization procedures for preparation processes at blood and tissues establishments
2) developing a concept model for a European knowledge-sharing platform that can support CAs in the assessment and evaluation of novel preparation processes of products
3) developing an international network of experts that can support CAs in the assessment and evaluation of preparation processes of products, trained by the Joint Action
© 2018 GAPP JOINT ACTION | WP2: Dissemnination & Communication