EURO GTP II – Development of 3rd level of methodologies

WP Leaders and Coordinators met in Leiden (29th November 2017) to determine the standardized development of contents that will be defined as 3rd step of the methodologies. These methodologies intend to facilitate the design of the studies, required to demonstrate quality and safety, following a systematic method. A template protocol will incorporate the specific tests addressing the corresponding risks identified in the 2nd step of the methodologies. The tests will also consider the Tissue and Cellular Therapies/Products (TCTP) preparation process indicators and the endpoints of the preclinical and clinical stages when applicable. This standardized approach aims to facilitate the work of the leaders of the technical WPs (6, 7 and 8), to develop harmonized contents that determine the studies (pre-clinical and clinical) and follow up programs.

Tissue & Cells Database: The Tissue and Cells (T&C) database aims to be compendium of tissues/cells products, preparation processes, applications and therapies., and will include information related with the characterization and availability of TCTP in the European Tissue Establishments . A guidance document describing the goals and information that will be included in the database was developed in simultaneous with an online prototype. Partners are now invited to test the suitability of this proposal, and give feedback in order to improve this tool, before the formal request to introduce data in the final database.

Sheli Kuperman