The EU-funded Horizon project IMMUTOL held its 2nd progress meeting in Budapest this week. Project partners came together to review key milestones, exchange updates, and align the next steps of this innovative EU-funded project. Asphalion, as the is their regulatory partner of the project and leader of Work Package 6, is guiding the consortium through the appropriate regulatory pathway.
At the meeting, our experts Montse de Castellarnau and Irene Urrecho gave an interactive seminar on regulatory guidance for the development of engineered VitD3DC for human therapy, focused on the Innovation Task Force (ITF) meetings, the Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB) regulatory documents required for a clinical trial.
IMMUTOL’s objective is to pave the way for new tolerogenic cell-based therapies to cure/reverse several autoimmune conditions, developing a more potent and durable treatment for autoimmune diseases with an unmet medical need, particularly Multiple Sclerosis.
Check out the IMMUTOL website for more information on the project.
For further information or regulatory support for your HORIZON project, contact us at [email protected].
