Fleming, in partnership with The QARP (Quality Assurance Research Professionals), has announced The GxP Quality x AI Innovation Summit, a two-day cross-disciplinary event for quality assurance professionals across GCP, GMP and GDP. The summit takes place on 9–10 March 2027 in Amsterdam.
The event is built around a single question: how do regulated organisations put AI into GxP operations without creating new compliance and inspection risk?
Why now
Pharmaceutical quality teams are already dealing with the consequences of ungoverned AI use. Regulatory warning letters have begun citing AI overreliance, inspection findings have been built on fabricated AI-generated content, and shadow AI is spreading through GxP-adjacent work, with 77% of scientists reported to be using public AI tools on personal accounts.
At the same time, the regulatory framework is tightening. EU GMP Annex 22 sets an expectation of inspection readiness by end 2026. The EU AI Act's general obligations took effect in August 2026, with high-risk provisions following in December 2027 and August 2028. ICH E6(R3), the ISPE GAMP AI Guide and emerging FDA guidance add further requirements.
"AI adoption is moving faster than governance," says Maxim Bunimovich, Conference Chair and CEO & Co-Founder of The QARP. "Tools are entering regulated workflows before organisations have clearly defined their intended use, risk classification, validation, human oversight and ongoing monitoring. The gap is not access to technology, but the evidence needed to demonstrate control."
Programme
The agenda is organised around the questions auditors and inspectors are likely to ask: who is accountable, what was validated, how outputs are reviewed, and how performance remains controlled over time.
Day 1 — The regulatory landscape has changed
Opening keynote on the regulator's view of AI submissions from the inside. A fireside session and moderated panel on whether regulation is keeping pace with AI. Sessions on EU GMP Annex 22 in practice, ICH E6(R3) and AI in clinical quality, and a panel on bridging GMP and GCP. Afternoon splits into Track A (GCP) and Track B (GMP/GDP), followed by four roundtable groups and a case study on shadow AI use.
Day 2 — What actually works
A keynote on a top-20 pharma's AI transformation, covering what worked, what failed and what it cost. Panel discussion on moving from pilot to production. Sessions on AI in CAPA and deviation management, pharmacovigilance signal detection, supplier and CRO qualification, and document management and SOP drafting. Two parallel hands-on workshops — Classify and validate, and Govern your AI — close the programme, alongside a panel and agentic AI fireside on regulatory intelligence.
Live mock inspection
A distinguishing feature of the programme is a live regulator-critiqued mock response session on Day 1. A mock Form 483 is presented to the room, followed by two pre-drafted AI responses, a live critique from an invited regulator, and a hallucination reveal.
"Accountability under AI is something you feel in the moment of being questioned, not something a slide can teach," says Mate Buki, Life Sciences Manager at Fleming.
Event details
The GxP Quality x AI Innovation Summit
📆9–10 March 2027, Amsterdam, The Netherlands
🧩Format: 20+ senior thought leaders, 15+ presentations and case studies, 120+ senior expert attendees, 6+ hours of networking, 2 interactive workshops, 4 roundtable groups, 1 live mock inspection
Registration: https://in.fleming.events/qaxai-mp-ie-reg
Enquiries: alexandra.skaromnik@fleming.events
