ON-DEMAND

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

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

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

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

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

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