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Patient Engagement Resource Center

Published by EATRIS

Patient EngagementResearch and Drug DevelopmentPatient Information

The Patient Engagement Resource center is an easy to navigate platform to help researchers get started with patient engagement in research. This toolbox provides helpful resources to help researchers understand the basics of patient engagement, and guide them through the different phases of patient engagement, from planning to conducting and evaluating.

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Research Management Manual

Published by EATRIS

Research and Drug DevelopmentTranslational Research

The EATRIS Research Management Manual provides general guidance on how to structure and run a translational research project, from project initiation to project closure, to optimize the translational feasibility of your project.  It also provides the necessary tools and templates, based on best practice experience and established project management methodologies. 

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Target Product Profile

Published by EATRIS

Translational Medicine supportEATRISProject Management

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

Translational Medicine supportProject ManagementEATRIS

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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The Assay Guidance Manual

Published by EATRIS

Target Validation Drug DevelopmentResearch and Drug DevelopmentDrug Discovery GuidelineSmall MoleculeDrug RepurposingNCATSNIH

This manual is a comprehensive resource for early drug discovery, providing guidelines for developing therapeutic hypotheses, validating targets and pathways, and establishing proof of concept criteria. It includes analyses of costs at various stages of drug development. The content encompasses critical decision-making points in New Chemical Entity (NCE) development, exploratory Investigational New Drug (IND) processes, and orphan drug designation. Furthermore, it delves into Drug Repurposing and drug delivery technologies, making it an invaluable guide for professionals initiating new drug discovery and development programs.

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