This flyer outlines the 5-step evaluation for SOHO preparation processes (PPA). It details risk classification and criteria for granting full authorization, conditional authorization, or refusal.
The second newsletter summarizes the results achieved between August 2025 and March 2026: SOHO Regulation implementation, GAPP methodology testing, and cross-country assessments. It serves to keep stakeholders updated
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.
The first Newsletter sums up the Joint Action so far: key activities, early results, coordination milestones, and cross-country collaboration. It keeps stakeholders informed and aligned with progress and what's next.
This leaflet presents the GAPP-PRO Joint Action and serves to inform and engage stakeholders by offering concise details about the Joint Action's goals, partners and more. Web version.
The "D2.1 Communication Plan" outlines strategies for sharing results of the GAPP-PRO Joint Action. It covers visual identity, target group identification, dissemination, and sustainability
This document details media strategies for the GAPP-PRO Joint Action. It showcases the project website, explaining its structure, operation, and content. WP2 Leaders designed the site as a public information tool
This document contains the amendments proposed by the European Parliament to the Commission's regulation on standards of quality and safety for substances of human origin intended for human application.