The Committee for Orphan Medicinal Products (COMP) organized their Plenary Meeting last week (13-15 February), that was chaired by Regulatory Scientific Committee (RSC) Vice Chair, Violeta Stoyanova-Beninska, and Armando Magrelli. Among the topics discussed were the new applications for orphan medicinal product designation (including amendments of existing designations), requests for protocol assistance with significant benefit question, review of orphan designations at time of initial marketing authorization, extensions and many more.
More details about the event: https://www.ema.europa.eu/en/documents/agenda/agenda-comp-meeting-13-15-february-2024_en.pdf