European Infrastructure for Translational Medicine (EATRIS)

EATRIS is a European Research Infrastructure Consortium (ERIC) founded to defragment the European substantial efforts in translational research. Its mission is to improve productivity of the translational R&D pipeline by providing high quality research services to public and private research entities. Comprising over 80 leading research institutions located in twelve countries across Europe, EATRIS has been a key player in the biomedical innovation continuum. By bringing together multi-disciplinary expertise, facilities and patient resources to support the development of promising drugs and diagnostics, EATRIS accelerates and de-risks the path to clinical proof of concept and partners with key stakeholders for the validation and introduction of novel tools to support R&D.

Role in the TRANSVAC project

EATRIS involvement in TRANSVAC2 will include primarily the development of a regulatory platform for preclinical, marketing authorisation and pharmacovigilance for clinical trials. In addition, EATRIS will seek to identify inconsistencies in the national regulatory frameworks while offering consultation on preclinical vaccine development (WP16). Additionally, EATRIS will be leading a task to secure the long-term sustainability of the vaccine infrastructure and will be actively involved in the drafting of a business plan in order to mobilise the necessary support for the further implementation and ultimately the long-term operation of the infrastructure.

Main staff involved in TRANSVAC

David Morrow, Vaccines Platform Manager, EATRIS-ERIC; Jiri Deml, Regulatory expert, Brno University (Linked third party of EATRIS) ;Lucia Gabriele, Research leader, ISS (Linked third party of EATRIS)

The Facility

The infrastructure consists of non-profit research institutes that engage in collaborative research and services in the translational phase of preventive, diagnostic and therapeutic product development. EATRIS offers the entire spectrum of high-end research infrastructure and patient cohorts all accessible though just one portal, and maximises product potential by providing support from discovery to clinical trials. The services offered cover the areas of advanced therapy medicinal products, biomarkers, imaging and tracing, small molecules and vaccines. The EATRIS vaccines platform offers services covering the entire vaccine development and production pipeline ranging from late-phase pre-clinical development to clinical trials, and comprises fourteen institutions.

TNA or Training provided

EATRIS will develop a training workshop dedicated to regulatory aspects of vaccine development that will be delivered twice over the project’s lifetime. Participants will learn how to plan a regulatory strategy from the early phases of development and prepare a well-organised dossier in a changing regulatory environment.

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Description