Key Takeaways
Learn what is changing, what stays the same, and where regulators are placing their attention when assessing AI-enabled systems.
Decode Annex 22 and the updated Annex 11
Learn what is changing, what stays the same, and where regulators are placing their attention when assessing AI-enabled systems.
Learn from the first FDA AI Warning Letter
Go inside the April 2026 Warning Letter to see what crossed the line, and the controls that would have prevented it.
Prepare for global expectations
Gain practical guidance for how Nordic and European companies can navigate AI compliance while operating in both the EU and the US markets.
The rules for AI in regulated environments are no longer theoretical.
In April 2026, the FDA issued its first Warning Letter citing misuse of Artificial Intelligence in pharmaceutical manufacturing. At the same time, Annex 22 is nearing finalization, the Annex 11 revision is following close behind, and AI-related obligations under the EU AI Act are already coming into force.
For the first time, Nordic and European Life Science companies face concrete enforcement pressure from regulators on both continents regarding AI. The next six months will shape how AI is governed in regulated environments for years to come.
Organizations that establish the right governance, validation, and compliance foundations today will be better positioned to adopt AI confidently and avoid costly remediation later.
Whether you are already using AI or still evaluating its potential, this webinar will help you understand what regulators expect and what actions you should prioritize next.
But what does all this mean for quality, validation, compliance, and business leaders trying to turn AI ambitions into a compliant reality?
Join Epista Life Science and our expert, Henrik Johanning, for a practical webinar that connects the latest regulatory developments with the actions life science companies should be taking today.
