Expert mentoring service for rare diseases researchers

Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE

EATRIS

Within the EJP RD, EATRIS offers an expert mentoring service for rare disease researchers. 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.
The mentoring programmes provides mentoring on
* Translational feasibility
* Regulatory compliance
* Product classification
* Quality assurance and control
* Intellectual property strategy
* Suitability of analytical readouts
* Manufacturing
* Therapy development

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Training on translational medicine/ TRANSMED ACADEMY

Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE

EATRIS

EATRIS offers a wide range of training, including:
– How to assess the translational potential of your project
– How to develop a collaboration with industry
– An introduction to translational medicine (this is particularly relevant for PhD students and postdocs).
– EATRIS also offers open access to an e-learning environment dedicated to translational research

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Computational model of biological systems

Provided by ISBE NL

Make Me My Model ( 4M 4U): Non modellers can obtain (assistance with) the making of a computational model of their biological system. If we can, we shall make you your model such that you can run it, use it to make predictions of the schemes you have in mind and compare that with your experimental results. Contact isbe@nl to make you a model of an experimental biological or medical system you are researching. In this way we can establish whether we have the modelling expertise to help you or can refer you to other isbe nodes

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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. Our range of services include:

– 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.

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