Core set of FAIR software tools and set of unified FAIR data standards applied in EJP RD

Published by

Project ManagementFAIRData management

This EJPRD deliverable describes a suite of tools, resources, and standards that align with the FAIR principles and have been verified as supporting the Virtual Platform architecture that is being generated by the EJP RD. It is recommended to utilise and implement these resources in your proposal to help FAIRify your data. 

View this resource Bookmark this resource

A target product profile (TPP) outlines the desired characteristics of a new drug or other medical intervention (e.g diagnostic tool). TPPs describe intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. In industry TPPs are used as planning tools that guide development towards desired characteristics. In the regulatory context, TPPs are considered as tools to frame development in relation to submission of product dossiers.

View this resource Bookmark this resource

Expert Mentoring Service Information Sheet

Published by EATRIS

Project ManagementEATRISTranslational Medicine support

Advancing promising technologies and therapies towards clinical application is a complex undertaking. Academic research often lacks easy access to regulatory, therapy development expertise, manufacturing, and healthcare practice, leading to high failure rates. For this reason, the European Joint Programme on Rare Diseases (EJP RD) has initiated a mentoring programme for rare disease researchers. The aim of the mentoring is to increase the impact and patient benefit of the excellent science funded in EJP RD. With this mentoring support, applicants will receive project-specific feedback from a panel of drug development, biomarker validation, methodological and regulatory experts tasked with optimizing the translational feasibility of the study.

View this resource Bookmark this resource

EATRIS Translational assessment services

Published by n/a

Project ManagementEATRISTranslational Medicine support

EATRIS supports your investigators in assessing and optimising the translational feasibility and potential of the projects that your are interested in funding. By providing feedback to you and the investigator on issues such as medical need, market and pipeline overview, regulatory pathway, intellectual property and translational tools, you have more confidence in selecting high potential projects, and investigators can optimise their plans according the realities of the development pipeline.

View this resource Bookmark this resource