WP 8: Refine of GAPP Guideline

Objectives

Update the GAPP Guideline to authorization on preparation process in blood, tissues and cells, developed in GAPP JA, taking advantage of the results of the pilot tests as well as the opinions of the different professionals and competent authorities that have taken part in the pilot tests;
extend the existing EUROGTPII platform to other SoHO so to provide European professionals with the opportunity to perform risk assessment also for other products.

WP leaders

ISS/CNT-CNS (IT) and OCATT (ES)

Beneficiaries

ABM (FR), HTO (EL), HPRA (IE), TRIP (NL), PUMS (PL), SZU (SK), UTCC (UA)

Affiliated entities

ANSM (FR), BST (ES), ONT (ES), MOH (ES), TICSALUT (ES)