Recorded live at AI in GxP West
How Large Enterprises Pilot AI in GxP
From idea to proof of concept: how a global pharmaceutical organization frames, tests, and governs an AI pilot inside a regulated environment, and what it takes to move one past the proof stage.
Stephen J. Cook
Senior Director, GRC CSO and Tech Operations, Global Digital & Tech, GSK
What you'll take away
- Choosing a first use case with a real owner and a measurable outcome
- The evidence a quality organization needs before a pilot is taken seriously
- The risk and accountability questions that decide whether a pilot ever scales
- Where enterprise pilots stall across IT, quality, and the business, and what separates the ones that don't
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How Large Enterprises Pilot AI in GxP
Sessions like this one are what AI in GxP East is built on. Keep scrolling for 35+ more, live in Raleigh on September 15 and 16.
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AI in GxP East
Early Bird rates end August 14 · From $1,795 · Register 3, the 4th is free
September 15 and 16, 2026 · Raleigh, NC
Where the rest of the sessions are.
Two days, 35+ case study sessions, and a faculty of practitioners who have already put AI into validated environments: governance, deviation intelligence, audit trail automation, continuous validation, and the inspection questions nobody has clean answers to yet.
Featured session · Day One
Defining Ownership and Accountability for AI Across GxP
Subhabrata Purakayastha, Associate Director and Head of Enterprise GxP IT Systems Quality, Incyte
Who signs for an AI system, where quality, IT, and the business each hold accountability, and escalation pathways that work when the model behaves unexpectedly.
Also on the agenda
Defining Acceptance Criteria for AI Validation
Abhishek Bachchan, Associate Director, IT Security, Risk and Quality, Gilead
How to make an intelligent system testable when the output is not deterministic, and what defensible evidence looks like after the model changes.
“A must-attend event for me in 2026, confirmed through the quality of the speakers and breadth of content. It answered key questions and sparked a wealth of ideas.”
AI in GxP West attendee
Speaking from inside the regulated world
Who is on the faculty.
Case studies from the quality, validation, and IT leaders accountable when AI touches a GxP system.
Bristol Myers Squibb
Gilead
Medtronic
Incyte Corporation
iRhythm
Guardant Health
MedStar Georgetown University Hospital
RCM Life Sciences and IT
PSC Biotech
PQE Group
Zifo Technologies
CIMCON Software
Compliance Group
Genari AI
QACV Consulting
CenPharma
Phanero
ProcellaRx
RiskCortex Limited
Systera Solutions
Aldren.ai
Validfor
Vaisesika Systems Consulting
Tuple
RxT
SWARE
One Vector
See 35 more sessions like this one.
Raleigh, September 15 and 16. Early Bird rates end August 14.
Manufacturer $1,795, rising to $1,995 after August 14 · Solution provider $1,995, rising to $2,195. Attend in person or virtually.
