AI in Pharma 2026: when the question changes from “can we?” to “can we defend it?”

 ProductLife Group at AI in Pharma 2026: from innovation to responsible implementation 

October 2026 | Kraków, Poland

Most life sciences companies have an AI pilot running somewhere. Far fewer have brought one into daily operations under GxP. The obstacle is rarely the technology itself. It is what surrounds it: governance, data you can trust, validation that follows risk, and a clear path to regulatory compliance.

This was the starting point for ProductLife Group (PLG), Main Sponsor of AI in Pharma 2026, organised by ISPE Poland Affiliate and GAMP CoP Poland. Over several weeks, from an online webinar to the closing panel in Kraków, our experts explored one question: what does it really take to bring AI into a regulated pharmaceutical environment?

A conversation that began before Kraków

AI can move quickly from an idea to a promising pilot. Moving it into a GxP environment is a different challenge. How should an AI workflow be classified according to regulatory risk? What level of validation does it require? Which safeguards must be built in from the start? And can the system stand up to regulatory scrutiny?

On 13 October, the webinar “Deploying AI in the GxP World” opened the discussion. Naomi Ofili and Gabrièle Piaton shared PLG’s methodology for taking AI from pilot to validated, inspection ready production, drawing on three concrete projects and looking at risk based classification, the validation considerations it drives and the safeguards required by design.

What stood out in Kraków

Four ideas ran through the sessions.

AI adoption is entering a new phase. The conversation is moving from experimentation to implementation. Organisational readiness, practical value and sustainable governance now matter as much as the technology.

Validation must evolve. AI brings new considerations: probabilistic behaviour, ongoing performance monitoring, and the need to maintain confidence throughout the lifecycle of a system, not only at go live.

Human accountability remains essential. As AI takes a larger role in decision making, clear responsibilities, meaningful oversight and the ability to challenge outcomes become more important, not less.

Collaboration is key. Solutions that work in real GxP environments need technology, quality, regulatory and business expertise in the same room.

PLG on stage

Our experts contributed to the programme throughout the event:

• “Yes, you can use AI in a GxP environment: here’s how.” Ross Wareing presented on AI readiness, looking at the real barriers companies run into, the solutions that work in practice and the governance framework that holds everything together.
• “AI under inspection: can you defend your system?” Ross Wareing and Natalia Sammler led an interactive workshop on AI inspection readiness, focused on vendor selection, validation, ongoing compliance and audit readiness.
• “Accountability in the Age of Autonomous Systems: Who Signs Off When a Machine Makes the Decision?” Magdalena S. moderated the closing panel, a fitting question to end the event on.

From deployment to governance and inspection readiness, the three sessions addressed different stages of the same challenge: turning AI innovation into controlled, compliant use in GxP environments.

The question to ask next

The closing panel’s title is also the best test for any AI project: if a machine makes the decision, who signs off, and can that person explain why?

Organisations that can answer are the ones that will move from pilot to production. Those that cannot will find out, sooner or later, during an inspection.

AI innovation creates opportunities. Responsible implementation turns them into lasting value.

Is your organisation ready for an AI inspection? Our experts can help you assess where you stand and what comes next. Discover our Digital & Innovation servicesfrom AI, technology and data migration to digital quality and validation, and talk to the team about your AI and GxP challenges.