#RBQMLive
RBQM 2024 On-Demand
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: Taking RBQM into New Dimensions – Understanding the Risk-Based Data Management (RBDM) Revolution
Speakers:
Miguel Valenzuela, Associate Director of Clinical Operations, RBQM, Alnylam
Paul MacDonald, Senior Director Vault CDMS Strategy at VeevaPanel
Patrick Nadonly, Global Head, Clinical Data Management, Sanofi
- 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
Panel: The Emergence of AI & ML in RBQM: What’s here now and what is to come?
Speakers:
Marcin Makowski, Head of Centralized Monitoring & Data Analytics, GSK
Bob Zambon, Vice President, Growth Solutions & Technology Enablement, Syneos Health
- 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: RBQM Industry Guidance Evolution – Adapting to Modernization
Speakers:
Olivia Feiro, Director, Risk Management & Analytics, CSL Behring
Lotte Smets, Director Data Management, Julius Clinical
Daniel DiJohnson, Risk-Based Quality Management SME, Senior Manager, Parexel
- 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
Enhancing Data Quality through Advanced Audit Trail Review
Speakers:
Paola Peshkepija, Senior Associate Central Monitor, Pfizer
Jennifer Nielsen, Senior Specialist, Clinical Data Management, Lundbeck
- 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
Speakers:
Brian Barnes, Director of Risk Management Strategy – Process Excellence & Oversight, BioNTech
Jess Thompson, Founder, Clinical Research Project Management Association
Alaine Heffernan, Director Centralized Monitoring, Allucent
- 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
