- Save the Date · Nov 16-17, 2027
- Conference
AI in GxP: Europe
Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe's Pharma Industry
- Nov 16-17, 2027
- Frankfurt, Germany
Special Rate ends December 31
Need approval? Download a justification letter
Overview
Europe Is Writing the Rules for AI in GxP.
Annex 22 sets expectations for AI used in GMP, the revised Annex 11 updates computerised system requirements, and the EU AI Act adds obligations of its own. Each one matters on its own. Together, they define how AI gets deployed in Europe. This event connects them into one practical approach.
Built for Europe
Sessions walk through Annex 22, the revised Annex 11, and the EU AI Act side by side, with a focus on where they overlap and what they require in practice.
From the people doing it
You will hear from European manufacturers and sponsors who are deploying AI under these rules, and from experts close to how they are being interpreted and inspected.
Outcomes
What you'll leave with
Annex 22
What Annex 22 expects for AI in GMP: intended use, model selection, test data, performance criteria, and human oversight.
Annex 11
How the revised Annex 11 applies to the systems AI runs on, from supplier oversight to security and periodic review.
EU AI Act
Which GxP use cases may fall under the AI Act, what obligations follow, and how to align them with GMP requirements.
AI Governance
Building one governance framework that satisfies Annex 22, Annex 11, the AI Act, and FDA expectations.
Validating AI Models
Risk-based validation of machine learning and generative AI using GAMP 5 Second Edition and the GAMP AI guidance.
Inspection Readiness in the EU
How European inspectors are approaching AI and what documentation they expect to see.
Who should attend
Built for the People Who Have to Control AI.
- VP, Director, and Head of Quality, Validation
- AI, Automation, and Center of Excellence Leads
- CSV and CSA Managers and Specialists
- Qualified Persons and QA Managers
- Regulatory and Compliance Leads
- Digital Transformation and Innovation
- Regulatory Affairs and Compliance
Group Pricing
Bringing 6 or more attendees?
Send your team for less. Tell us about your group and the KENX team will follow up with special group pricing for the AI in GxP
Europe
Group pricing
Tickets
Need approval to attend?
Download a justification letter
A ready-to-send letter for your manager with key sessions, takeaways and pricing.
Venue & Travel
Frankfurt, Germany
November 16–17, 2027
· In person only
Venue and hotel room block details will be announced.
11 Events · North America & Europe
2027 Conference Schedule
Advance your professional development in the GxP and validation landscape.
Full agendas and registration coming soon at KENX.org
AI in GxP: Puerto Rico
Validation University
Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It
AI in GxP: Pilot to Production to Scale
Real Deployments. Real Validation. Real Scale.
GxP Laboratory Summit
Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs
CSV & CSA European Congress
Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice
Sterility Assurance University
Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation
AI in GxP: Guardrails & Governance
Risk, Oversight, Model Monitoring, and Inspection Readiness for AI
GCP & Clinical Operations Summit
Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials
GMP & Quality Operations Summit
Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It
AI in GxP: Europe
Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry
CSV & CSA University
Less Paperwork, More Assurance: Making the Move from CSV to CSA
Who should attend?
Professionals in pharmaceutical, biotech, MedTech, CDMO, and CRO organizations who own, validate, govern, or approve AI in EU-regulated operations.
Is there a virtual option?
No. AI in GxP: Europe is an in person only event in Frankfurt, Germany on November 16–17, 2027.
What's included in my pass?
Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.
Are group rates available?
Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.
What's the cancellation policy?
KENX does not issue refunds. If you are unable to attend after registering, we are happy to apply your registration fee toward a future KENX event or transfer your registration to a colleague. All cancellation or transfer requests must be received at least seven days prior to the event.
How do I become a sponsor or exhibitor?
Use the Become a Sponsor or Become an Exhibitor links, or contact the KENX team to discuss opportunities.
Please Note: KENX does not issue refunds. If you are unable to attend after registering, we are happy to apply your registration fee toward a future KENX event or transfer your registration to a colleague. All cancellation or transfer requests must be received at least seven days prior to the event.
