On 20th and 21st October, the Italian National Blood and Italian National Transplant Centre, as Coordinators of Joint Action, hosted the Intermediate Meeting of GAPP-PRO at the Istituto Superiore di Sanità premises in Rome.
The first half day gathered Work Package Leaders and Co-Leaders, together with DG SANTE representatives, providing an important opportunity to review progress and exchange perspectives on follow-up activities. The second day featured a plenary meeting with the entire Consortium and External Advisory Board. Discussions focused on consolidating achievements, identifying next steps, and reinforcing the collective effort towards a harmonised European approach to the authorisation and assessment of Substances of Human Origin (SoHO) preparations.
The presence of DG SANTE representatives underlined the strong collaboration that supports GAPP-PRO’s mission. This partnership is reflected in several ongoing initiatives designed to foster convergence, build capacity, and enhance regulatory practices across the EU.
Among these, a training session organised on 28th and 29th October stands out as a concrete example of cooperation. Led by tutors from the European service SIGHTSoHO , the session was addressed to the SoHO Coordination Board (SCB) working group on SoHO Preparation Authorisation (SPA). It focused on presenting the GAPP and GAPP-PRO methodologies, supporting a consistent, risk-based approach to SoHO authorisation procedures. This joint training initiative represents an important step forward in aligning practices and strengthening the link between EU-level regulatory developments and operational implementation in Member States.
In parallel, the GAPP-PRO Consortium continues to collaborate closely with DG SANTE and DG DIGIT in the testing of the EU SoHO Platform, specifically the SPA module. The feedback focuses on two key aspects: the design of the SoHO Preparation Compendium and the platform’s core functionalities. The insights collected will guide improvements to usability and ensure the system effectively meets regulatory objectives and end-user needs.
These collaborative initiatives highlight GAPP-PRO’s dedication to assisting the European Commission in developing a robust, user-friendly, and scientifically grounded framework for the SoHO field. Continued cooperation with DG SANTE, DG DIGIT, and HaDEA is essential for establishing a coherent, sustainable European approach that ensures the safety, quality, and accessibility of SoHO.
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