Jesper Madsen Wagner

Building the Foundations for AI in GxP Environments

Before AI can transform the Life Science Industry, the foundations must be in place.
In this session, Jesper Madsen Wagner, Expertise Director at NIRAS, takes you behind the buzz to focus on the real prerequisites for responsible AI in regulated environments.

You’ll learn why success depends not just on models, but on:

• Deep domain and process knowledge to frame AI use cases correctly.
• Reliable data availability and quality as the bedrock for compliant AI.
• A clear view of regulatory requirements—from validation to lifecycle oversight.

Rather than asking “What can AI do?”, this talk asks, “What must we do first?” It provides practical guidance for building a digital and compliance foundation that turns AI into a trustworthy tool for life sciences.

Bio:
Jesper Madsen Wagner is Expertise Director – Medical Devices at NIRAS, where he leads advisory services at the intersection of GxP compliance, digitalisation, and emerging technologies. 
With more than two decades of experience in life science and medical device environments, Jesper supports companies in transforming regulatory requirements into practical, value-creating solutions.
He works closely with executive management, quality, engineering, and IT functions to design and implement robust validation strategies covering facilities, equipment, processes, and computerized systems. 

In recent years, his focus has increasingly been on how artificial intelligence and advanced data analytics can be responsibly introduced in regulated environments—without compromising patient safety, data integrity, or regulatory compliance.
Jesper is the author of the white paper “Building the Foundations for AI in GxP Environments”, which explores how organisations must establish strong digital, data, and governance foundations before AI can deliver real and sustainable value in GxP-regulated operations. 
His work emphasizes risk-based validation, lifecycle thinking, and “trust by design” as key enablers for successful AI adoption.

At IDA Life Science Annual Conference, Jesper shares practical insights on what it truly takes to make organisations “AI-ready” in GxP environments—bridging strategy, regulation, and real-world execution.