In Silico Evidence Training for Frontline Regulatory Reviewers
The UK Centre of Excellence on In Silico Regulatory Science and Innovation (UK CEiRSI) kicked off its two-day training workshop in London on 14–15 October 2026, at the invitation of the International Medical Device Regulators Forum (IMDRF)
Coordinated by UK CEiRSI, the Avicenna Alliance, and the VPH Society, the workshop was designed for international regulators, national competent authorities, and conformity assessment bodies, including Notified Bodies and Approved Bodies.
As in silico modelling becomes increasingly important throughout the therapeutic product life cycle, the evidence it generates is playing a growing role in regulatory submissions. The workshop provided an opportunity for regulatory authorities, developers, and scientists to exchange knowledge, engage in open scientific discussion, and share perspectives on reviewing in silico evidence.
The training aimed to strengthen reviewers’ practical ability to assess computational modelling and simulation results as regulatory evidence for medical devices and combination products. Drawing on clinical, regulatory, industry, and technical perspectives, the sessions explored how to assess fitness for purpose, identify limitations, and ask proportionate questions.
The workshop attracted strong international interest, with representatives from the UK, EU, Japan, Australia, Switzerland, and South Korea. Through two-way dialogue, the initiative supports knowledge sharing, greater alignment in regulatory expectations, and international collaboration while recognising regional differences.
The sessions were recorded and will be shared on the UK CEiRSI YouTube channel
