In the context of the EATRIS-Plus project we are looking for independent experts to set up an EATRIS Regulatory Task Force. To this end, the call for expression of interest for experts is now open.
The EATRIS-Plus Consortium is composed of 20 partners including all current national nodes of the research infrastructure EATRIS-ERIC, academic representatives of new prospective member countries as well as umbrella organisations representing the patients’ voice and biotech companies. The project is funded by the EC’s H2020 programme and coordinated by EATRIS-ERIC. The project aims to build further capabilities and deliver innovative scientific tools to support the long-term sustainability of EATRIS as one of Europe’s key research infrastructures for personalised medicine.
One task of the EATRIS-Plus project is to expand catalog of services by setting up an EATRIS Regulatory Task Force composed by a maximum of ten EATRIS Regulatory Experts.
Foreseen activities will include:
- Act as an intermediary contact point with National Competent Authorities on behalf of EATRIS academic members, and liaise with relevant activities planned by the H2020-funded STARS project.
- Monitor the European Medicines Agency (EMA) ’s plan for further interaction with academia and 2025 strategy implementation, and activities of EMA working groups, such as the Joint Big Data Taskforce.
- Explore the possibility to offer regulatory support for research grant applicants as a fee-based service.
- Liaise with European Patients’ Forum representatives on the increasing role played by patients in regulatory work and latest relevant policy developments.
- Create a platform for knowledge and experience exchange, to share experiences with the community and collect national requirements, with a view to identify harmonization opportunities
The areas where the regulatory expertise is needed include:
- Development of medicinal products. Products covered: small molecules biologicals (including vaccines and blood products), biotechnology-derived products, advanced therapy medicinal products
- Development and validation of manufacturing process, validation of analytical development and qualification of analytical methods, variation and change in the process, viral safety evaluation
- Regulatory expertise in terms of filing and assessment of the technical dossier to be submitted for clinical trials to regulatory authorities
- Development of in vitro diagnostics
- Development of medical devices
The activity within the group will not be financially compensated but will allow the experts to be part of an exciting team and to support, in the best way possible, enthusiastic researchers in writing and implementing innovative European projects and in increasing their awareness of regulatory requirements. Furthermore, they may have the opportunity to provide advice to companies and academia as part of EATRIS Regulatory services (on a fee or collaboration basis depending on specific project) and participate in EU-funded projects (Horizon Europe in particular) to lead research projects’ regulatory strategy on behalf of EATRIS.
Interested experts willing to participate and become a great asset to this initiative should send an email with a short CV (maximum 500 words) and a motivation letter (maximum 500 words) to email@example.com
For any further clarifications or questions you might have, please, write to firstname.lastname@example.org.
Please note that this expression of interest to participate in the EATRIS Regulatory Task Force is NOT binding and does NOT constitute any commitment to the EATRIS-Plus project.