IMAGE GALLERY:
Avicenna Alliance at the IMDRF Meeting in Sapporo – September 2025
27/10/2025
BACK
The Avicenna Alliance had the honour to attend the International Medical Device Regulators Forum (IMDRF) meeting in Sapporo, hosted by the PMDA. As an observer to IMDRF, the Alliance joined the open sessions to engage with global Regulatory Authorities, the WHO, Trade Organizations, and industry representatives.
Representing the Alliance, Mark Palmer (Ansys, part of Synopsys) and Alex Frangi (University of Manchester), Co-Chair of the UK In Silico Regulatory Innovation Task Force, highlighted the growing momentum behind in silico methods and their potential to transform regulatory science.
For the first time, Alex Frangi, representing the Avicenna Alliance and UK CEiRSI, presented a lecture entitled "DIGITAL EVIDENCE FOR THE DIGITAL ERA Evidence-based on In Silico Technologies; Computational Modelling and Simulations Model-Informed Evidence: Why to Harmonise, and Why to do it Now? " on Day 3, during the closed door session.
Conversations with regulators — FDA, MHRA and TGA — and stakeholders such as Colvin Heather (Johnson & Johnson) provided valuable guidance before the presentation as well as inspiring suggestions for follow up activities. These discussions further illustrated the growing importance of in silico methods and the need for global harmonisation and confirmed the interest from regulators and stakeholders in prioritising in silico within future IMDRF guidance.
The Alliance looks forward to building on these outcomes and advancing the role of digital evidence worldwide.
