Neuronet included four Working Groups (WGs) for cross project discussions. One of these WGs was the HTA and Regulatory interactions WG that aimed to generate insight into regulatory and HTA challenges that are unique to neurodegenerative diseases. The WG activities included organising a workshop to discuss the projects activities around digital endpoints and the challenges faced in using them in regulatory and HTA submissions, and conducted/performed case studies to illustrate HTA and regulatory interactions for a number of IMI ND projects. This white paper summarises these activities as well as the key learnings, and is an output of Neuronet’s Work Package 3 (WP3) which explored tools and services for ND products.
D3.11 Regulatory, HTA, and payer strategy for neurodegenerative diseases
