Patients all over the world should benefit from the achievements of predictive medicine and the introduction of in silico trials, which promise the accelerated and safe introduction of new products such as medical devices or pharmaceuticals to the market place. These concepts cannot be developed by academics or in industry alone, and ultimately they need to be accepted by regulatory agencies around the world. When regulators accept simulation augmented submissions, and agree upon a common model credibility assessment philosophy will patients benefit from the utilization of in silico medicine.
The objective of the Avicenna Alliance International Working Group is the promotion of the benefits of predictive medicine and in silico trials through the global connections of experts from academia, industry, and regulatory agencies. Together we will work on developing objective standards, increasing confidence in in silico methods and their acceptance in support of regulatory approval process.
The key goals of this group are:
- Continue facilitating dialogue on in silico with regulators and actors around the world and seek opportunities to expand the Alliance geographically by actively engaging with priority countries, and following-up with additional countries.
- Reach global convergence and harmonization on the regulation/ guidance for the use of in silico as evidence.
Priorities in 2019 and 2020
→ Identification of strategic contacts and implementation of an outreach plan;
→ Participation in international events to represent the Avicenna Alliance;
→ Planification and organisation of local events;
→ Contribution to the upcoming Avicenna Alliance White Papers.
Working group leader:
- Markus Reiterer
- Distinguished Scientist, Technical Fellow, Medtronic, PLC (Minneapolis, USA)