Pharma quality teams are already facing regulatory warning letters citing AI overreliance, inspection findings built on fabricated AI-generated content, and shadow AI use spreading through GxP-adjacent work with 77% of staff turning to ungoverned tools — all while EU GMP Annex 22 and the EU AI Act’s high-risk provisions close in fast.
The GxP Quality x AI Innovation Summit brings together senior QA, regulatory, and compliance leaders across GCP, GMP, and GDP to convert AI ambition into validated, inspection-ready practice — grounded in real enforcement cases, not hype.
WHY ATTEND?
Get ahead of the rules that are about to bind you:
Understand what EU GMP Annex 22, ICH E6(R3), and the EU AI Act's 2027 high-risk provisions actually require — and where the current guidance stops short, leaving you to decide how much risk is acceptable.
Close the gap between shadow use and sanctioned AI:
Build a practical inventory and risk register for the AI already running inside your quality system, and take home a governance model that covers vendor- embedded AI, not just the tools you built yourself.
Turn compliance into operating advantage:
See documented results — faster deviation closure, reduced audit-prep time, earlier CAPA detection — from organizations that treated AI governance as a capability to build, not just a box to check.
