Healthcare all over the world, should benefit from the rapid advances and the introduction of in silico methods in medicine. As realized n other industries, the application of in silico methods in medicine promises accelerated innovation and improved quality in the delivery of medical devices and pharmaceuticals to the marketplace. The valuable contribution of in silico methods as a complimentary source of evidence for regulatory submissions will not be achieved through academics and industry alone. Ultimately there needs to be strong collaboration with regulatory authorities around the world.
The objective of the Avicenna Alliance International Working Group is the promotion of the benefits of predictive medicine and in silico methods through the global connections of experts from academia, industry, and regulatory agencies. Together we will work on developing policies and standards, increasing confidence in in silico methods and promote the added value of in silico evidence to the regulatory approval process.
The key goals of this group are:
- Facilitating dialogue on in silico with regulators and stakeholders around the world;
- Supporting harmonization and regulatory reliance policies for in silico methods and in silico clinical trials;
- Seek opportunities to expand the Alliance geographically.
Priorities 2023 - 2024 and beyond:
2023:
- Pursue observer status with IMDRF and potential attendance to IMDRF EU conferences;
- Organize an IMDRF event for modeling & simulation socialization in Brussels;
- UK TF – Support UK Regulatory Roundtable for development of In Silico Standards;
- Support the launch and strategic initiatives of the APAC Task Force.
2024:
- Strategy for formal ongoing IMDRF engagement;
- Organize local event with APAC regulators;
- Participate in international events to represent the Avicenna Alliance.
2025 and beyond:
- Continue to develop strategy and engagement for addressing regulatory policy needs across geographies;
- Collaborate with other Avicenna Alliance Working Groups to accumulate artifacts and successful in silico applications for engagement with Regulators and Notified Bodies.
Working Group Leader
Nathalie Virag, PhD
Distinguished Scientist & Bakken Fellow, Corporate Technology and Innovation, Medtronic
