elluminateSummer Series
The Ins and Outs of RBQM
The latest evolution of clinical trial guidance is changing how sponsors are expected to approach trial oversight, quality management, and risk. Regulators are no longer emphasizing risk-based monitoring alone but are calling for integrated, continuous, cross-functional risk management throughout the trial lifecycle. Most organizations understand the theory behind RBQM. The challenge is operationalizing it.
In our three-part Summer Series, we break down the latest guidance and explore how teams can employ effective, impactful RBQM strategies.
RBQM 101: What the Latest Guidelines Say, and How This Impacts Your RBQM Strategy
June 25 | 11:00 AM EST
ICH E6(R3), ICH E8(R1), and updated MHRA expectations: What is the latest guidance saying, and how have expectations surrounding RBQM changed? How do these changes impact your current operations? How do you translate evolving guidance into practical processes?
This session will break down the latest regulatory guidance, explore what it requires in practice, and outline the operational shifts needed to support modern RBQM.
Presenter
Vera Pomerantseva
Director of Product Management, RBQM
Vera Pomerantseva is a clinical research and risk management leader with extensive experience in risk-based quality management (RBQM), clinical data analytics, and quality strategy.
From Silos to Synergy: How Tech Can Make or Break RBQM
July 23 | 11:00 AM EST
Are your data review and risk management processes truly connected — or are critical functions still operating in silos?
This session will explore the operational gaps between data management, medical monitoring, and central monitoring that limit effective risk-based oversight. It will examine how fragmented workflows, disconnected review plans, and inconsistent definitions of critical data create inefficiencies and reduce visibility into meaningful study risks.
Presenter
Jason Konn
Associate Director of Solutions Consulting
Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has led design & development for several products, including Risk Based Quality Management.
What’s Next for RBQM? AI, Integrated Oversight, and the Future with elluminate
August 25 | 11:00 AM EST
As clinical complexity increases, it’s almost certain that regulations surrounding RBQM will continue to evolve, and this is especially true as AI advancements accelerate.
This session will explore emerging trends shaping the future of RBQM and demonstrate how modern platforms like elluminate RBQM can help organizations operationalize strategies designed for both today’s regulatory environment and tomorrow’s evolving demands.
Presenter
Jason Konn
Associate Director of Solutions Consulting
Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has led design & development for several products, including Risk Based Quality Management.