September 24th - 25th, 2024
2024 Agenda
Day One Sessions
Day Two Sessions
Keynote: Unlocking the Path to RBQM Maturity
Speaker: Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development

  • Explore evidence-based insights on the evolution of RBQM adoption
  • Uncover factors driving and hindering the journey towards RBQM usage maturity
  • Gain actionable insights from recent empirical research findings

Panel: RBQM Industry Guidance Evolution – Adapting to Modernization
Olivia Feiro, Director, Risk Management & Analytics, CSL Behring
Lotte Smets, Director Data Management, Julius Clinical

  • Discuss opportunities and challenges with evolving guidance updates
  • Understand strategies for integrating quality by design into clinical trial design and execution
  • Examine approaches to ensure inspection readiness

Panel: The Emergence of AI & ML in RBQM: What’s here now and what is to come?
Speaker: Marcin Makowski, Head of Centralized Monitoring & Data Analytics, GSK

  • Explore real-world applications of AI & ML in RBQM
  • Discover how AI-driven machine-learning can revolutionize data analysis for increased efficiency
  • Learn key insights into the evolving AI & ML landscape and the research-backed benefits of AI & ML in RBQM

Panel: Taking RBQM into New Dimensions – Understanding the Risk-Based Data Management (RBDM) Revolution
Miguel Valenzuela, Associate Director of Clinical Operations, RBQM, Alnylam
Paul MacDonald, Senior Director Vault CDMS Strategy at VeevaPanel

  • Explore how RBQM identifies real-time “outliers,” such as training deficiencies or fraud, and enables prompt corrective action
  • Integrated data review: Explore the integration of RBQM and RBDM to ensure comprehensive risk management
  • Gain insights into real-world applications of integrated data review and data quality oversight

Enhancing Data Quality through Advanced Audit Trail Review
Speaker: Coming Soon!

  • Explore the role of audit trail review in detecting risks and improving data quality
  • Gain insights into detecting anomalies in various audit trail data sources
  • Use case: Uncover how audit trail data helped detect risks in data quality

Panel: Integrated Data Review: Optimizing Study Oversight
Brian Barnes, Director of Risk Management Strategy – Process Excellence & Oversight, BioNTech
Jess Thompson, Founder, ACRPM

  • Best practices for leveraging technology to facilitate data review
  • Access the right data at the right time for informed decision-making
  • Gaining insights into effective collaboration strategies for study oversight

*All times are in Eastern Standard Time (EST)