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.
EATRIS is proud to be a partner in the #PERMITproject, which has seen another publication (this time in BMJ_Open) that provides a review of the study designs used for #ClinicalTrials in #PersonalisedMedicine. 👉 Find out more about the publication hereatris.eu/news/new-publi…0M0 https://t.co/6AlAFsz2IL
EATRIS is proud to be a partner in the #PERMITproject, which has seen its 2nd review published in the JPM_MDPI titled “Methods for Stratification & Validation Cohorts: A Scoping Review”. 👉 Find out moreeatris.eu/news/new-publi…K#PersonalisedMedicineeECRIN_ERICIN_ERIC https://t.co/MGwVg3uqYV