Policy Development (PD) Working Group
The European Commission has entrusted the Avicenna Alliance with a pivotal mission: supporting the implementation of the Avicenna Roadmap within European policy.
Through its Policy Development Working Group, the Avicenna Alliance is helping shape a future-ready regulatory landscape that fully embraces the potential of in silico technologies. As many existing EU policies and regulations were developed before the emergence of these innovative approaches, there is a clear need to modernize the framework governing healthcare innovation.
By advancing the validation and regulatory acceptance of modelling and simulation, the Avicenna Alliance is paving the way for greater investment, accelerated innovation, and the wider adoption of in silico technologies across healthcare and research.
The Policy Development Working Group Mission is to work towards:
- A forward-looking policy framework to facilitate the large scale deployment of in silico technology and their acceptance by health authorities.
- To significantly reducing time and cost for health care technologies approval and reimbursement and fostering medical innovation, including for those conditions with pressing unmet medical needs such as rare diseases and pediatric applications.
The key goals of this group are:
- Inform European and US authorities about the benefits brought by in silico medicine;
- Advocate for the inclusion of CM&S (Computer Modelling and Simulation) in legislation, policy guidelines and research funds;
- Collaborate with health care stakeholders on in silico guidance and CM&S benefits dissemination, ensuring that in silico clinical trials become a pillar of drug and medical device development programs, when appropriate.
Priorities 2025 - 2027 and beyond:
2025:
- Establish collaboration with EC stakeholders;
- Define pathway to submit digital evidence to support CE marking;
- Define GSP in collaboration with FDA, EMA, MDIC and InSilicoWorld;
- Promote in silico medicine for Pharmaceutical application;
- Educate stakedholders via NB TF, Pharma Strategy and PPI TF.
2026:
- Identify policies mentioning payers to promote in silico medicine
- Foster collaboration with European Commission
- Promotion of GSP vis-à-vis Worldwide Policy makers (with Int. WG);
2027 and beyond:
- Sustain in silico advocacy for Medcial Devices and Pharmaceuticals
CLICK HERE FOR POLICY DEVELOPMENT WG INTRO
Martha De Cunha Maluf-Burgman, WG Leader
