Fondazione Gianni Benzi joined in the 2nd ERDERA General Assembly 2025, held this year in Amsterdam and bringing together the European community committed to rare disease research. It was an important moment not only to review the outputs of the first year of the project, but also to contribute to the discussions that will shape its future direction.
The Foundation brought to Amsterdam its regulatory and ethical expertise, along with long-standing experience in supporting researchers. Fedele Bonifazi, President of the Foundation, presented – also on behalf of Annalisa Landi and Giuseppe Digregorio – the ongoing work to develop a consultancy-based support service for projects funded by ERDERA, and the broader rare diseases research community. This work is based on the identification of the needs of the research community and the definition of the most effective business model. All interested stakeholders are invited to contribute through this survey!
Ethics and regulatory aspects were also at the centre of the plenary session, where Annalisa Landi and Silvia Torretta, researchers from the Foundation, presented the current progress of ERDERA’s ethical and regulatory activities and outlined the next steps that will guide the programme’s evolution.
Back-to-back the ERDERA General Assembly, Viviana Giannuzzi, Head of the Research and Innovation Department, chaired the Workshop on “Qualifying innovative methodologies and tools for rare disease research” organised for ERDERA Regulatory Support Group. Representatives from not-for-profit organisation, academia, patients, industry and regulators discussed and shared views on how the tools and approaches developed in the project can make studies for drug development more robust and more meaningful for patients with rare diseases through the qualification by EMA.
The participation of Fondazione Gianni Benzi in the General Assembly was therefore far more than a formal engagement: it was an opportunity to strengthen its role within ERDERA and to contribute to building a more coordinated European ecosystem capable of responding to the needs of the rare disease community.
