The aim of the mentoring is to increase the impact and patient benefit of the excellent science funded in ERDERA. 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. There are no costs or obligations to you.
View this resource Bookmark this resourceTranslational Project Management
This section contain materials useful to learn how to manage an Innovation Project
The Playbook provides a practical, user-friendly guide to navigating the complexities of data sharing in IMI/IHI collaborative health research projects, outlining key concepts, roles, decision points, common challenges, and strategies to address legal, technical, and organisational obstacles. It encourages early planning, stakeholder engagement, and adoption of standardised best practices to accelerate data sharing and improve research efficiency across multi-partner consortia
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TTO Guidance and assessment model for Socially Responsible Licensing and Negotiation
Published by FAST (Centre for Future Affordable & Sustainable Therapy Development)
LicensingNegociationTTOThis guide is designed to assist Public Research Organizations (PROs), including universities and university medical centers, in enhancing the potential for their scientific discoveries to benefit society through commercialization (valorization). To achieve this, it is essential to convert research findings into practical applications (innovation). Typically, this is facilitated by private entities that utilize intellectual property (IP) licensed from PROs. The purpose of this guide is to simplify this challenging process.”
The corrected version resolves typos and uses clearer language to improve readability and professional tone
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Research Management Manual
Published by EATRIS
Project ManagementResearch and Drug DevelopmentTranslational ResearchThe 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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Core set of FAIR software tools and set of unified FAIR data standards applied in EJP RD
Published by EJPRD
Data managementFAIRFAIRificationProject ManagementThis 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 resourceWhen you plan in reverse, you start with your end goal and then work your way backwards from there to develop a plan of action. Working backwards in this way can give you a much clearer picture of what and how much must be accomplished during each phase of a project. It can also help you identify and avoid unnecessary activities
Bookmark this resourceA 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
EATRISProject ManagementTranslational Medicine supportAdvancing 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.
Bookmark this resourceCORBEL is an initiative of thirteen new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research
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EATRIS Translational assessment services
Published by n/a
EATRISProject ManagementTranslational Medicine supportEATRIS 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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