On 12 July, the PERMIT project held an online working session to discuss the regulatory gaps in the personalised medicine research pipeline. Gathering over 30 participants from within and beyond the PERMIT consortium, the session focused on the gaps and questions identified through the scoping reviews and consultation exercises. These items include the design, building and management of stratification and validation cohorts, the use of machine learning and artificial intelligence for patient stratification and the use of preclinical models for the development of personalised therapeutics and for the mimicking of patient clustering. The gaps that were presented and discussed by all attendees represented areas where the requirements and regulatory expectations are unclear or lack harmonization, where the methodological approaches do not seem to be covered by the regulatory texts and guidelines, or areas where regulatory requirements could dampen innovation. Representatives from HTAs, national competent authorities, the European Commission, the EMA, consulting companies specializing on regulatory aspects of medical devices and in-vitro diagnostics, and experts from the pharmaceutical industry shed light on the current regulatory framework in Europe, on pragmatic approaches for navigating the framework and on what can be expected from the regulations in the coming years.
What is happening in the #PERMITproject? This month marked the final #PERMITproject workshop to define recommendations for robust and reproducible preclinical research in #personalisedmedicine. Learn more about the 5 themes to guide these recommendations permit-eu.org/article/recomm… https://t.co/KdkFKmgwJZ
2020 was the 1st year of the #PERMITproject. Learn about the project and consortium accomplishments in the interview with Project Manager, PaulaGarLobato. 📙Find it on p48 of our Annual Reporecrin.org/reports-brochu…50A 📽️Watch the video youtu.be/Z_EjW1MdElAMtejr0RM https://t.co/pqFfzWfjpZ