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Clinical trial teams today are operating under extraordinary pressure. With ICH E6(R3) reshaping global expectations, sponsors and CROs must not only prove inspection readiness, but also embed Quality by Design principles, demonstrate ROI, and keep pace with disruptive technologies like AI and audit trail analytics. Cultural resistance, siloed adoption, and talent gaps only intensify the challenge— leaving organizations vulnerable to missed risk signals, wasted resources, and compromised trial quality.
The 6th Risk-Based Quality Management Summit is your chance to cut through this complexity with clarity and practical strategies. By learning and networking with our expert faculty, you’ll gain tools to move RBQM from theory to sustainable practice, align cross-functional teams on quality ownership, and secure executive buy-in with evidence-based business cases. Sessions will spotlight how to:
- Implement QbD that drives measurable outcomes across every trial phase
- Overcome cultural and change-management barriers to lasting RBQM adoption
- Harness AI, audit trail analytics, and advanced metrics for proactive risk detection
- Translate ICH E6(R3) compliance into operational and strategic wins
- Quantify the financial ROI of RBQM deployments with new Tufts CSDD research
- Build and staff the “dream team” needed for a post-E6(R3) world
…and much more! Join RBQM leaders January 13–14, 2026, in Philadelphia to get the latest regulatory insights, learn from real-world case studies, and future-proof your risk-based quality management strategy.
Topics covered will include:
- Choosing and Managing Vendors with a Focus on Risk Management
- Identify Essential Steps in QTL Development
- Prioritize the Fundamentals of Risk
- Learn from Past Mistakes in Data Integration
- Leverage Metadata to Inform RBQM Analysis
- Central Monitoring/Site Monitoring
- Clinical Quality Assurance
- Risk Evaluation & Adaptive Integrated Monitoring
- Data Management
- Site Engagement
- Clinical Business Operations
- RBM/ RBQM
- Clinical Operations
- Clinical Research Compliance
- Risk/Risk Management
- Data Monitoring
- Site Monitoring
- Data Sciences
- Study Monitoring
- Clinical Research
- Clinical Protocol Lead
- Clinical Standards and Innovation
- Research Quality
- R&D Quality
- Regulatory Affairs
- Study Lead
- Clinical Quality
- Clinical Operations & Compliance
- GCP Quality Assurance
- Clinical Outsourcing Analytics
- Trial Feasibility
“The sessions were great and shared multiple experiences, perspectives, and practical applications for current day challenges.” – Head, Risk Evaluation & Adaptive Integrated Monitoring, MERCK
“All sessions brought unique perspectives and I left with new ideas from each one.” – Head, Centralized Monitoring, BRISTOL-MYERS SQUIBB
“I'd recommend this event to colleagues! Great conversations, networking, and idea sharing." – Manager, Central Monitoring & Data Analytics, GSK
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