Services offered by EATRIS include advice on intellectual property issues and industry partnering strategy (innovation management)
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The Netherlands
Expert mentoring service for rare diseases researchers
Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
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
Training on translational medicine/ TRANSMED ACADEMY
Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
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
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.
Support for funding applications
Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
EATRIS supports funding applications including:
• Identification of partners for consortium building
• assessment of the project plan’s impact and innovation potential
• training to strengthen the proposal.
Fostering industry – academia collaborations
Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
To facilitate academic collaborations with industry, EATRIS provides research services geared towards biotech SMEs and pharmaceutical companies such as:
• Molecular imaging studies for drug (target) evaluation and biodistribution
• Preclinical and clinical PET/CT, PET/MRI and (ultra) high field MRI imaging
• Ex-vivo, organoid, PDX and animal models (including non-human primates)
• Access to clinical samples and biobanks, rare patient cohorts
• Scientific/medical experts and KOLs, rare patient populations
• Development and validation of in vitro assays
• Cell tracking, immuno-monitoring
• Biomarker validation: NGS, deep genome sequencing, mass spec and multi-omics analysis
• Regulatory advice for the development of advanced therapies (ATMP) and repurposing and Orphan Drug Designation
Health Technology Assessment expertise
Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
Services offered by EATRIS include regulatory and Health Technology Assessment (HTA) expertise
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