Despite their enormous potential, the adoption of in silico methodologies in the regulatory evaluation of biomedical products is growing slowly.
During the three years of activity, the In Silico World consortium conducted two qualification advice procedures with the European Medicines Agency and engaged with notified bodies, national authorities, and standardisation bodies. In this report, we provided detailed documentation of all these activities so that any other interested party can learn from our experience.
But “Regulatory barriers to the adoption of in silico trials” is more than an extensive report on such activities, it also summarises and analyses the In Silico World consortium’s work concerning the regulatory barriers and draws some recommendations for EU policymakers, which can be summarized as follows:
- Separation
- Interdisciplinarity
- Unification
- Patience
To learn more check the full report for free here.
