The Interreg COHERENCE project – Cross Border Health Regulatory Alliance for Advanced Therapies – has launched a digital platform that supports researchers and clinicians in regulatory compliance for cell-based Advanced Therapy Medicinal Products.
COHERENCE promotes a collaborative approach to research and development processes by capitalising on the experience gained by interregional partners in Italy and Slovenia.
ICGEB, as the lead partner in the project, is pleased to announce the launch of a digital platform that supports researchers and clinicians in regulatory compliance for cell-based Advanced Therapy Medicinal Products (ATMPs).
The web platform is available in three languages (Italian, Slovenian, and English). It offers a clear map of national (Italian and Slovenian) and European regulations, provides templates and checklists of the necessary forms for both countries (including the CTIS guide), and includes experimental protocols, publications, and conference information.
Through a pilot action, the project aims to develop an open platform to guide researchers in regulatory compliance. It involves the design and conduct of a clinical trial to treat difficult wounds. In addition to advancing the development of an effective treatment for difficult wounds, the trial will test the platform, which will then be opened and expanded to encourage the participation of other research groups at the European level.
The platform has been designed as an open, modular, and scalable tool to accelerate the transition from preclinical to clinical safely and ethically and to incorporate and integrate regulatory updates and new content.
