224W26-Logo_Web-1
October 13-14, 2026
369W25-Convene White2
Philadelphia, PA 

Bringing Together Clinical Quality, Clinical Operations, and Digital Innovation Leaders to Operationalize AI in Clinical Development

Previous Attendees

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Where Clinical Quality, Clinical Operations, Regulatory Affairs, Data Management, Digital Innovation Leaders Converge to Build AI-Ready Quality Systems

The AI Clinical Quality Summit is the only senior-level forum dedicated to the intersection of artificial intelligence, GxP compliance, and clinical quality management — bringing together the leaders responsible for making AI work in regulated clinical environments.

This is not a theoretical discussion. Every session is focused on practical application, scalable implementation, and the real-world lessons organizations have learned moving AI from proof-of-concept into inspection-ready, enterprise-wide quality systems.

Three Value Pillars

Strategic leadership

For the leaders driving the future of clinical quality

  • Join a senior-level community dedicated to practical AI implementation in GxP-regulated environments
  • Sharpen your approach to risk-based quality, continuous monitoring, and compliance
  • Gain real-world strategies for moving AI from pilot to enterprise-wide adoption
  • Discover proven frameworks for maintaining inspection readiness in an AI-enabled world
  • Leave equipped to lead your organization's transition from reactive to predictive quality management
Peer network

A network that understands your challenges

  • Connect with peers across Clinical Quality, Clinical Operations, Regulatory Affairs, Data Management, and Digital Innovation
  • Share implementation lessons and hear how organizations are scaling AI beyond early-stage pilots
  • Build relationships with leaders navigating the same GxP compliance and data integrity pressures
  • Exchange insights on vendor oversight, deviation management, and audit-readiness in an AI-enabled environment
  • Expand your network with professionals who understand what it takes to execute in regulated environments
Practitioner focus

Content built for practitioners, not theorists

  • Agenda designed around real-world AI implementation challenges in clinical quality — not hypotheticals
  • Interactive case studies and working sessions on predictive monitoring, CAPA automation, and data integrity
  • Focus areas: AI in risk-based monitoring, GxP validation, clinical data quality, deviation management, and change management
  • Practical tools and proven frameworks to strengthen compliance, accelerate reviews, and reduce manual burden
  • Leave with actionable strategies to drive measurable quality outcomes across your trials

Top reasons to attend

01
Move from reactive to predictive quality
Learn how leading organizations are using AI to identify risks before they impact trials — not after.
02
Tackle GxP compliance head-on
Get real guidance on validating AI/ML models in regulated environments and aligning with evolving FDA and global regulatory expectations.
03
Strengthen clinical data integrity
Discover how AI is being applied to detect anomalies, automate data review, and uphold ALCOA+ principles across EDC, CTMS, and external data sources.
04
Learn from the field
Every session features leaders who have implemented AI in clinical quality — sharing what worked, what didn't, and what they'd do differently.
05
Build lasting industry connections
Network with senior executives from pharma, biotech, and CROs who are actively solving the same problems you face.

2026 Speakers

Meet the Minds Behind Our Awesome Event

Jamie Toth

Jamie Marie Toth

Senior Director Trial Master File Management & Records

BeOne

Geetanjali Abbi

Geetanjali Abbi

Head of Digital, Director, Quality Assurance

Alkermes Logo

Dawn Lundin

Dawn Lundin

Vice President, Global Quality Executive Leader

Summit focus areas

 
 
01

From reactive to predictive quality

Transitioning from audit-driven models to continuous, AI-powered risk management

 
 
02

AI in clinical trial oversight

Enhancing risk-based monitoring with machine learning and real-time site visibility

 
 
03

GxP compliance & AI validation

Validating AI/ML models, ensuring explainability, and aligning with regulatory expectations

 
 
04

Clinical data quality & integrity

Automating anomaly detection, data reconciliation, and query management

 
 
05

Deviation, CAPA & risk management

AI-driven root cause analysis, trend identification, and CAPA cycle improvement

 
 
06

Change management & adoption

Scaling AI beyond pilots and building AI-ready quality organizations

 
 
 
 
 
 

Pricing

Pharma / Biotech Companies
Best Value

Super Early Bird

Register by 04/17/2026

$1,695

Save $600!

Early Bird Register by 06/05/2026
$1,895 Save $400
Advanced Rate Register by 07/10/2026
$2,095 Save $200
Standard Rate Register after 07/10/2026
$2,295
Solution Provider / Vendor Companies
Best Value

Super Early Bird

Register by 04/17/2026

$2,295

Save $800!

Early Bird Register by 06/05/2026
$2,495 Save $600
Advanced Rate Register by 07/10/2026
$2,895 Save $200
Standard Rate Register after 07/10/2026
$3,095

Venue

 

 

convene-logo

TWO COMMERCE SQUARE

2001 Market Street, Philadelphia, PA 19103

 

View Map ➜

Please note there is no exclusive housing block for this event.  If you are contacted by a 3rd party housing company claiming to have a relationship with Momentum Events Group LLC, or its event,  these companies and others like it are not in any way affiliated with us.

2026 Sponsorship

 

Position your brand in front of the Clinical Quality, Clinical Operations, and Digital Innovation leaders actively evaluating and implementing AI in regulated environments. Sponsorship packages are designed to drive meaningful visibility, thought leadership, and curated connections with decision-makers across pharma, biotech, and CRO organizations.

Interested in learning more?

Schedule a meeting with our sponsorship team

 

Frequently Asked Questions

 

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