The EChiLiBRiST project held its first CGA meeting in Barcelona last week. The EU-funded project main objective is to develop and validate a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival.
Asphalion will lead the regulatory activities of the EChiLiBRiST project, in which an In-Vitro Diagnostic System (IVD) will be developed for a better prediction of mortality and monitoring of endothelial physiopathology in children in low- and middle-income countries.
To this purpose, Asphalion will accompany the consortium in the elaboration of the Regulatory plan, that will include:
- Strategic regulatory roadmap
- Design and Development, Risk Management, Usability and Software Validation
- Quality Management System (QMS support).
- Regulatory Support in IVD Performance Studies
- Regulatory Support in exploring CE Marking, FDA Approval and local approval in other regions.
During the meeting, Asphalion expert Diego Sanoja had the chance to present the Regulatory Challenges, discuss the regulatory milestones for the EU, USA and other regions, as well as local regulatory requirements about performance study sites in Mozambique, Gabon and Ethiopia.
The project is funded by The European Union under the Horizon Europe Programme and counts with the participation of 12 institutions from Europe, the United Kingdom, Africa and Canada and will be implemented on a duration of 5 years.
For further information, you can contact us at: [email protected]
This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement Nº 101057114
