UK CEIRSI Two-Day In-Person Workshop

The UK Centre of Excellence in Regulatory Science and Innovation (UK CEiRSI) and the Avicenna Alliance, with the MHRA, invite expressions of interest for a two-day, in-person training workshop:

Building Confidence in In Silico Evidence in Regulatory Affairs across the Medical Product Lifecycle

The workshop will build on the introductory webinars delivered on 29 July 2026 and provide an intensive, interactive exploration of how computational modelling, simulation, and in silico evidence can be assessed within regulatory submissions.

Who is the workshop for?

This workshop is intended for frontline technical and clinical assessors who routinely review regulatory submissions and may need to evaluate in silico evidence as part of a wider package of evidence.

Expressions of interest are open to individuals working within: National regulatory authorities, UK Approved Bodies. EU Notified Bodies.

This workshop is not open to industry participants.

Applicants must be available to attend both days in person.

What will the workshop cover?

Through practical examples, facilitated discussions and hands-on breakout activities, participants will explore how credibility is established for in silico evidence, how to apply risk-informed credibility frameworks to example submissions, how to identify key questions for sponsors, and how regulatory assessment approaches can be applied across orthopaedic, cardiovascular, and combination/drug-delivery device case studies. Participants will work with peers and faculty towards a shared and proportionate approach to assessing model-informed evidence.

What will participants gain?

• Apply a risk-informed credibility framework (ASME V&V 40 / emerging ISO/IEC 63739-2) to example submissions
• Formulate the key questions to put to a sponsor, and recognise both ‘red flags’ and the evidence that builds confidence
• Relate in silico methods to their own therapeutic area through hands-on breakouts
• Work with peers and faculty towards a shared, proportionate approach to assessing model-informed evidence

Attendance and costs

Attendance at the workshop is free of charge. Thanks to grant funding from UK CEiRSI, participants can attend at no cost, with the workshop offering a nominal value of approximately £2,000 per attendee.

Participants will be responsible for arranging and paying for their own travel and accommodation. Further venue and joining information will be provided to successful applicants.

Registration deadline: Friday, 28 September 2026 (1-week extension)

Full information here