Updated EUROGTP II Interactive Assessment Tool (IAT)

The Interactive Assessment Tool has been expanded to additional SoHO and supports structured, harmonised and stepwise risk assessments. It guides users in identifying novelty, assessing risks, and defining appropriate study and follow-up requirements.

The Euro GTP II Interactive Assessment Tool (IAT) has been developed to assist professionals involved in the provision of SoHO to:

•   Determine if the SoHO preparation or process has any novelty (Step 1)
•   Assess the risks associated with the SoHO Preparation or its preparation process (Step 2)
•   Determine the extent of any studies and/or follow up required to assure the safety and efficacy of the SoHO preparation/therapy. (Step 3)