- Save the Date · Oct 13-14, 2027
- Conference
GCP & Clinical Operations Summit
Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials
- Oct 13-14, 2027
- RTP, NC
Special Rate ends December 31
Need approval? Download a justification letter
Overview
E6(R3) Is Here. Now Make It Work.
ICH E6(R3) reframes GCP around quality by design, proportionate risk, and sponsor oversight. The guideline sets the principles. Implementing them across studies, CROs, sites, and technology vendors is the hard part.
Built for clinical operations
Sessions cover E6(R3) implementation, critical-to-quality factors, CRO and vendor oversight, centralized and risk-based monitoring, and validated use of AI and clinical technology.
From the people doing it
Speakers are clinical operations and clinical QA leaders from sponsors and CROs who are implementing E6(R3) now, sharing their processes and their inspection experience.
Outcomes
What you'll leave with
E6(R3) Implementation
Updating SOPs, training, and governance for E6(R3), and prioritizing what changes first.
Quality by Design
Identifying critical-to-quality factors and building quality into protocols before the first patient is enrolled.
CRO & Vendor Oversight
Sponsor accountability, oversight plans, KPIs, and audits that show you are in control of outsourced work.
Risk-Based Monitoring
Centralized monitoring, key risk indicators, and targeted on-site visits that improve data quality.
AI in Clinical Trials
Using AI for site selection, data review, and document workflows, and validating it for GCP use.
GCP Inspection Readiness
Preparing the TMF, sites, and vendors for FDA and EMA inspections under E6(R3).
Who should attend
Built for the People Who Have to Control AI.
- Clinical QA Managers and GCP Auditors
- Study and Trial Managers
- Vendor Oversight Leads
- Clinical Data and Systems Leads
- Pharmacovigilance
- Sites and SMOs
- Biotech
- MedTech
- Vendor and Outsourcing Management
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 GCP & Clinical Operations Summit
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
RTP, NC
Oct 13-14, 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?
This event is designed for clinical operations, clinical quality, and GCP compliance professionals in pharmaceutical, biotech, MedTech, and CRO organizations.
Is there a virtual option?
No. GCP & Clinical Operations Summit is an in person only event in RTP, NC on October 13–14, 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.
