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.

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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.

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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.

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