What to Expect at RBQMLive 2025: A Glimpse Into the Industry’s Leading RBQM Event

Welcome to the fifth annual RBQMLive—happening one day only on September 25. This free, virtual event brings together leaders from every corner of the clinical research world to explore the trends, technologies, and strategies shaping Risk-Based Quality Management (RBQM).

Whether you’ve joined us before or this is your first time, RBQMLive 2025 delivers a bold, forward-thinking agenda packed with fresh insights and real-world takeaways you won’t want to miss.

Download the full “What to Expect” guide, complete with the agenda, speakers, and more.

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Why This Event Matters

RBQMLive is the go-to global forum for all things RBQM. For one impactful day, regulators, Sponsors, CROs, and tech innovators gather virtually to share what’s working, what’s next, and how to stay ahead. If you work in or around clinical trials, this event was built for you.

Over the years, RBQMLive has tackled various topics that have shaped the industry’s approach to modern clinical trial oversight. Past sessions have explored:

• RBQM Strategy & Implementation: Real-world frameworks and field-tested insights to help teams operationalize RBQM effectively.
• Regulatory Guidance & Compliance: Deep dives into evolving global regulations, including ICH E6(R3), QTLs, and what they mean for your day-to-day.
• AI, ML & Emerging Innovation: Cutting-edge applications of Artificial Intelligence, Machine Learning, and automation in risk-based approaches.
• Data Management & Integrated Oversight: Best practices for centralized monitoring, data integrity, and collaborative review models.
• Research-Driven Insights & Industry Trends: Exclusive survey findings, benchmarking data, and expert analysis of where RBQM is headed.
• Tailored Applications of RBQM: Use cases and strategies for applying RBQM to specialized trial types, including rare disease and early-phase studies.

Missed previous sessions? Four years of RBQMLive insights are available on demand. Catch up here.

What’s New in 2025?

RBQMLive 2025 is all about measurable impact, forward momentum, and future-proofing your approach to quality. Here’s what sets this year apart:

• ROI Data: For the first time, Tufts CSDD will unveil research using Net Present Value (NPV) modeling to quantify the financial and operational return on RBQM.
• AI in Action: From protocol design to risk detection, discover how AI transforms RBQM with practical use cases and a look at what’s next.
• Fresh Perspectives: Hear from leading experts at Tufts CSDD, Pfizer, GSK, Sanofi, Deloitte, Parexel, Syneos Health, and CluePoints.
• Sharper Format: Three tightly focused sessions, delivered back to back. High impact, low disruption to your day.

Sneak Peek at the Agenda

RBQMLive 2025 brings together three powerhouse sessions that hit the heart of what’s shaping clinical trials today: ROI modeling, regulatory guidance, and AI. More than just trending topics, these forces actively redefine how trials are designed, monitored, and managed.

Each session is led by industry trailblazers and built to help you future-proof your approach to trial oversight. This isn’t an event you attend, take notes, and forget about. This is the kind of event where insights stick, conversations continue, and actions happen—starting the moment the sessions end.

Here’s what you can expect from this year’s lineup…

Measuring the Impact: Quantifying the ROI of RBQM

For years, the industry has embraced RBQM as a smarter, more efficient approach to clinical trial oversight. But what’s the measurable return? In this keynote, experts from the Tufts Center for the Study of Drug Development (CSDD) will unveil new data modeling that applies Net Present Value (NPV) analysis to RBQM implementation, offering a first-of-its-kind look at the financial and operational value of doing things differently. With links to ICH E6(R3) principles, this session provides a compelling case for investing in a more proactive, data-driven approach to quality.

Decoding ICH E6(R3): From Principles to Practice

What does ICH E6(R3) mean for clinical trial oversight, and how are leading Sponsors and CROs preparing for it? This session provides a dual perspective on interpreting the new principles, evolving quality strategies, and embedding RBQM and integrated data review into trial operations. Moderated by Parexel, the discussion will explore practical approaches to implementation, collaboration, and staying ahead of regulatory expectations.

Harnessing AI for RBQM: Current Innovations & Future Directions

AI has become a pivotal tool in enhancing data quality, streamlining processes, and mitigating risks in clinical trials. This insightful session will delve into the practical applications of AI in RBQM and explore strategies for effective implementation. It’s designed for professionals looking to leverage AI to enhance their RBQM processes and ensure regulatory compliance while improving trial outcomes.

Click here to explore each session’s learning objectives, meet the speakers and companies behind them, and dive into the bios of every expert taking the virtual stage. Ready to register? We’re ready to welcome you.