InSilicoUK
A UK Centre of Excellence in In-Silico Regulatory Science and Innovation supporting the Entire Product Lifecycle in Life and Health Sciences
Funder: Innovate UK — Regulatory Science and Innovation Networks
Period: 2024
Principal Investigator: Prof. Alejandro F. Frangi
Website: uk-ceirsi.org
overview
The InSilicoUK project aims to establish a UK Centre of Excellence in in-silico Regulatory Science and Innovation in the Life Sciences (UK CEiRSI) — see uk-ceirsi.org for the live Centre site. Our Centre will establish the tools, standards, and best practices for integrating evidence from computational models into the regulatory process as a new source of information.
discovery phase
The Discovery Phase will involve:
- Expanding partnerships and formalising the operating model.
- Engaging with regulators, compliance and standardisation bodies, and industry — building and expanding relationships.
- Investigating the drivers for regulatory trust based on ethical principles and public attitudes.
- Conducting a skills gap analysis to complete background information and data gathering.
mock submission challenges
To drive learnings and best practices for the next phase, we will define up to three in-silico mock submission challenges as concrete demonstrative examples of using in-silico approaches in different aspects of the regulatory process — developing a proposal for the Implementation phase.