ERDERA

The European Rare Diseases Research Alliance (ERDERA) aims to enhance the health and well-being of the 30 million individuals living with rare diseases (RD) in Europe. Its goal is to make Europe a global leader in research and innovation related to RD, thereby providing tangible health benefits to patients through improved prevention, diagnosis, and treatment. The partnership seeks to create a robust RD ecosystem, building on the achievements of previous programs by promoting patient-centered research, developing new diagnostic tools and pathways, and driving digital transformation that links care, patient data, and research. ERDERA also ensures the alignment of RD research strategies across various countries and regions. By structuring purposeful public-private collaborations that target interventions throughout the R&D value chain, the partnership aims to accelerate the journey from knowledge to patient impact, maximising Europe's innovation potential in RD. To achieve its goals, ERDERA is designed as a comprehensive, integrated, institute-like system with three core components: (i) funding, (ii) an in-house Clinical Research Network, (iii) education and training, (iv) supporting services both for the internal and for external RD community, such as ethics, regulatory and methodological expertise, a data hub, and an acceleration hub.

ROLE OF THE FOUNDATION

The Foundation leads the project ethics and regulatory activities, coordinating the Ethics Advisory Group and Regulatory Support Group. Through this key role, we guide beneficiaries on ethical issues following Horizon Europe guidance, perform ethics assessment and follow-up of ERDERA- funded projects, offer support to ensure compliance with up-to-date regulatory requirements, support regulatory procedures and advise on engaging with regulatory agencies, thus facilitating the translation of new therapies. Additionally, the Foundation has explored the feasibility to create a project consultancy service aimed at providing expert services to researchers engaged in the RD field.

MAIN CONTRIBUTION OF THE FOUNDATION

Deliverable 1.1 – Data Management Plan

Deliverable 5.1 - Networking Support Scheme Call document

Deliverable 18.1 - Set of Regulatory Recommendations for the Clinical Research Network (CRN)

Milestone 49 - Composition of the Regulatory Support Group and first Kick off meeting

Milestone 50 - First set of sources, guidance, recommendations and webinars delivered.

FUNDED BY: HORIZON-HLTH-2023-DISEASE-07-01, GA 101156595 , 2024-31 (www.cordis.europa.eu/project/id/101156595)