As the premier sponsor, CluePoints is helping to elevate RBQMLive as the industry’s leading event focused on the evolving field of risk-based quality management. Taking place virtually on September 24-25, 2024, RBQMLive is a free event designed for professionals involved in clinical trials who are keen to deepen their understanding of RBQM approaches.
RBQMLive 2024 builds on the success of previous events, offering participants cutting-edge discussions, workshops, and opportunities to engage with experts across the field. With a focus on RBQM best practices, regulatory updates, and emerging technologies such as artificial intelligence (AI) and machine learning (ML), this year’s event promises to equip attendees with the tools and knowledge needed to enhance clinical trial oversight and data management.
The event is expected to draw an even larger crowd than last year’s, which saw over 1,000 delegates from more than 375 organizations attend. In 2024, the event expands its reach, with fresh opportunities for collaboration and a sharper focus on optimizing data quality and risk management in clinical trials.
Growth of RBQM adoption
The event will kick off on September 24 with the keynote address, ‘Unlocking the Path to RBQM Maturity’, delivered by Ken Getz, executive director and professor at Tufts Center for the Study of Drug Development. Getz will provide evidence-based insights on the growth of RBQM adoption, highlighting both the drivers and barriers in the industry. His presentation will also offer practical takeaways from recent empirical research, aiming to guide organizations toward full RBQM maturity.
A key highlight of day one will be the session ‘Taking RBQM into New Dimensions’, which will delve into the evolving world of Risk-Based Data Management (RBDM). Featuring Miguel Valenzuela from Alnylam, Paul MacDonald from Veeva, and Patrick Nadonly from Sanofi, the discussion will examine how RBDM is reshaping the clinical trial landscape by enhancing data oversight. The panel will explore how RBDM offers a more granular view of data risk, helping organizations take RBQM practices to the next level.
Another much-anticipated session on day one is ‘The Emergence of AI & ML in RBQM: What’s Here Now and What is to Come?’ With speakers such as Marcin Makowski, head of centralized monitoring & data analytics at GSK, and Bob Zambon, vice president of technology strategy and strategic partnerships at Syneos Health, the session will explore how AI and machine learning are transforming RBQM practices, driving efficiency and precision in trial monitoring and data analytics.
Day two of the event will focus on the future of RBQM and how it can further improve data quality and study oversight. Olivia Feiro of CSL Behring, Lotte Smets of Julius Clinical, and Daniel DiJohnson of Parexel will discuss the ongoing evolution of RBQM industry guidance and how companies can adapt to new regulations and practices in the session “RBQM Industry Guidance Evolution – Adapting to Modernization.”
Reliable, regulatory compliant data
The theme of enhancing data quality will be addressed in a session titled “Enhancing Data Quality through Advanced Audit Trail Review.” Led by Paola Peshkepija from Pfizer and Jennifer Nielsen from Lundbeck, this session will highlight the importance of advanced audit trail review techniques in ensuring that data remains reliable and regulatory-compliant throughout the clinical trial process.
The event will conclude with an in-depth session on “Integrated Data Review: Optimizing Study Oversight,” which will feature Brian Barnes from BioNTech, Jess Thompson from Clinical Research Project Management Association, and Alaine Heffernan from Allucent. This session will focus on the practicalities of centralized monitoring and how integrated data reviews can streamline the oversight process, ensuring that risks are promptly identified and mitigated in real time.
Patrick Hughes, co-founder and chief commercial officer of CluePoints, emphasized the importance of RBQMLive in shaping the future of clinical trial management: “Risk-based quality management is evolving, and industry adoption is increasing fast. RBQMLive is a unique event that brings together global specialists and industry experts interested in this transformative approach to managing clinical trials. This year’s program is packed with new insights and opportunities, and we encourage everyone to register for this free event.”
RBQMLive 2024 promises to be the most comprehensive event yet, providing attendees with invaluable insights into the latest RBQM methodologies, tools, and regulatory advancements. By fostering discussions on emerging trends such as AI, ML, and enhanced data quality practices, the event aims to drive further adoption of RBQM, helping to improve the quality and efficiency of clinical trials across the globe.
