No clear regulatory pathways

The credibility assessment proposed in the ASME VV-40 technical standard is limited to models used to assess medical devices. Pharmaceutical products, Advanced Therapy Medicinal Products, and Combinatory products do not have yet an equivalent standard. Also, the VV-40 is not harmonized in the CEN standardization framework, which makes it unclear on whether it can be used in relation to CE marking submissions. “First in kind” qualifications of In Silico Trials methods for the evaluation of drugs with EMA are proceeding quite slowly. Also, we need to explore new regulatory pathways for class III medical devices and pharmaceutical products that allow a significant reduction of human experimentation with In Silico Trials technologies, and the adoption of a rigorous post-marketing surveillance that monitors the validity of the in silico predictions as the new product is adopted.

Our goal:

Technical standards and regulatory barriers: develop good regulatory practices for the qualification of In Silico Trial models to assess medical devices and medicinal products; pursue first in kind qualification of existing solutions.