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

Transforming Clinical Quality Through AI, Data, Processes, and Operational Impact

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
Build a Stronger Foundation for Clinical Quality
Explore proven approaches to improving quality, reducing risk, and embedding quality throughout the clinical trial lifecycle.
02
Prepare for Evolving Regulatory Expectations
Gain practical insights into ICH E6(R3), inspection readiness, vendor oversight, and maintaining continuous compliance across studies.
03
Strengthen Data Integrity and Traceability
Learn how organizations are ensuring reliable, inspection-ready data while improving visibility, documentation, and audit readiness.
04
Connect Clinical Quality with Clinical Operations
Understand how cross-functional collaboration between quality, operations, data management, and study teams can drive better outcomes and reduce downstream issues.
05
Learn Practical Applications of AI and Emerging Technologies
Discover how organizations are responsibly implementing AI and new technologies while maintaining human oversight, validation, and regulatory compliance.
06
Improve Risk Management and Quality by Design
Explore strategies for identifying risk earlier, proactively managing quality, and building more resilient processes.
07
Hear Real-World Experiences from Industry Leaders
Gain lessons learned, case studies, and practical approaches from pharmaceutical, biotechnology, and clinical research organizations.
08
Network with Peers Facing Similar Challenges
Connect with leaders in Clinical Quality, GCP Compliance, Clinical Operations, Inspection Readiness, Data Management, and Technology to exchange ideas and build new relationships.

2026 Speakers

Meet the Minds Behind Our Awesome Event

Geetanjali Abbi

Geetanjali Abbi

Head of Digital, Director, Quality Assurance

Alkermes Logo

David Ives

David Ives

Senior Director, Clinical Operations Systems

Madrigal Pharma

Jamie Toth

Jamie Marie Toth

Senior Director Trial Master File Management & Records

BeOne

Dawn Lundin

Dawn Lundin

Vice President, Global Quality Executive Leader

Summit focus areas

 
 
01

Clinical Quality & Compliance

Building robust quality systems, managing deviations and CAPAs, and embedding compliance into every stage of the clinical lifecycle

 
 
02

Inspection Readiness & ICH E6(R3)

Preparing for regulatory inspections and aligning quality practices with the latest ICH E6(R3) guidelines and global expectations

 
 
03

Risk-Based Quality Management

Shifting from reactive oversight to proactive, risk-based approaches for monitoring, decision-making, and continuous improvement

 
 
04

Data Integrity & Traceability

Ensuring ALCOA+ compliance, strengthening audit trails, and maintaining end-to-end traceability across clinical data sources

 
 
05

AI, Automation & Emerging Technologies

Practical applications of AI and automation to accelerate quality processes, from anomaly detection to predictive risk management

 
 
 
 
 

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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