Report on Competent Authorities' training needs for SoHO Preparation Process Authorisation: only 5 countries provide national training due to limited resources; 25 demand regular EU programmes.
The document outlines the update of the EuroGTP II Interactive Assessment Tool, a web platform for assessing the novelty and risks of Substances of Human Origin (SoHO) using a three-step algorithm.
This guide details the EuroGTP II methodology for assessing novelty and risks in substances of human origin, establishing frameworks for validation and clinical follow-up to ensure patient safety.