CluePoints releases full speaker lineup for free virtual event focused on risk-based quality management

CluePoints has announced the agenda for the fifth annual RBQMLive, a free virtual event bringing together clinical trial experts and quality leaders to discuss the future of risk-based quality management (RBQM). Scheduled for September 25, 2025, the event will focus on the practical application of RBQM principles in light of ICH E6(R3) updates, the return on investment in quality strategies, and the role of AI in trial oversight.

The 2024 edition attracted over 1,500 attendees from more than 290 organisations. This year’s programme builds on that momentum, offering data-led insights and practical guidance for sponsors and CROs integrating RBQM into their operations.

Highlights of RBQMLive 2025 include:

• Keynote: RBQM Fundamentals and ROI
  Ken Getz and Abigail Dirks from the Tufts Center for the Study of Drug Development will explore how RBQM aligns with ICH E6(R3), present new data models on return on investment, and outline strategies for implementation and stakeholder alignment.

• Panel: Decoding ICH E6(R3) – From Principles to Practice
  Speakers from Parexel, Deloitte and Syneos Health will offer sponsor and CRO perspectives on evolving quality strategies and integrating RBQM into operational frameworks.

• Session: Harnessing AI for Risk-Based Quality Management
  Focused on real-world use of AI tools to improve trial monitoring and data review, with discussion of future innovations and integration challenges.

Richard Young, Chief Strategy Officer at CluePoints, said: “With the release of ICH E6(R3), RBQM and integrated data review are no longer optional — they’re central to regulatory and operational success. We’re proud to support this event and bring the industry together for meaningful discussion.”

RBQMLive 2025 is free to attend and open to all trial professionals. Registration and full agenda are available online.