OF 17 - Towards regulatory-ready AI in radiology: integrating new approach methods and virtual clinical trials
Lectures
5 min
Chairperson's introduction
Federica Zanca, Leuven / Belgium
12 min
Scientific validity and standardisation of new approach methods (NAMs) and virtual clinical trials (VCTs) in AI radiology
Ehsan Samei, Durham / United States
To understand how R&I are advancing the scientific foundations of NAMs and VCTs for AI applications in radiology.
To review scientific frameworks for simulation reproducibility, interoperability, and benchmarking, and how they inform regulatory-science principles.
To connect these developments to ongoing European and global initiatives aiming at establishing reliable, ethically sound, and regulation-ready approaches for AI validation in medical imaging.
12 min
The industry perspective: how SMEs use virtual trial to generate regulatory-grade evidence for AI
Bruno Virieux, Saint-Étienne / France
To explore how innovators use synthetic and virtual data to train and validate AI tools in imaging.
To understand how NAMs and VCTs can address data scarcity, bias, and patient privacy challenges.
To identify opportunities and barriers to integrating NAM-based and virtual evidence into regulatory submissions.
14 min
The regulatory viewpoint: accepting simulation-based evidence for AI in radiology
Richard Holborow, Newport / United Kingdom
To review the evolving US/EU regulatory framework for AI-based medical imaging devices.
To discuss how simulation-based validation can support conformity assessment and clinical evaluation.
To outline pathways for recognition of virtual evidence in European regulatory practice.
17 min
Open forum discussion All speakers and
Ghada Zamzmi, Bethesda, MD / United States
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