When 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 activitiesView 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
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 facilitates academic collaborations with industry. It identifIes scientific & medical expertise and find the capacity to provide access to the latest technologies and core facilities from within our technology platforms.It serves as a single point of contact, provides (legal) support and acts as a negotiator to facilitate project initiation and monitor project execution when needed. Its infrastructure consists of 115+ biomedical research institutes in 14 EU countries.View this resource Bookmark this resource
Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.
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