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RBQM 2022 On-Demand

Keynote: How the Evolving RBQM Landscape Will Reinforce the Way We Improve Efficiencies and Add Value (Research Study Findings)

Speaker: Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development

Compliance is Key: ICH E6 (R3) & E8 (R1) Guidance Update

Speaker: Jonathan Rowe, Principal, Head of R&D Quality, Operations and Risk Management at ZS

Panel: Interpreting QTLs Through the Lens of Where They Are Today and Where They Are Evolving

Speakers: Marion Wolfs, Senior Director Risk Management & Central Monitoring, Janssen Joanna Florek-Marwitz, Data Management/Data Science/RBQM Senior Leader, UCB Steve Gilbert, Senior Director Statistics, Pfizer Moderator: Steve Young, Chief Scientific Officer, CluePoints

RBQM Diversification: tSDV, tSDR, Dynamic Site Monitoring Strategies

Speakers: Lesley Lardino, Senior Director, Data Management and Central Monitoring, Astellas Peter Stokman, Business Lead Clinical Data Reporting & Visualization Environment - Bayer Jacqueline Gough, Senior Director, Clinical Trial Management

Panel Discussion: Understanding the Risks of Decentralized Trials as Sources of Data Increase and How to Plan for Success Proactively

Speakers: Cris McDavid, Associate Director, Global Clinical Operations, RBQM, Parexel Joseph Dustin, Vice President of Product Strategy for eCOA at Medable Craig H. Lipset, Decentralized Trials & Research Alliance (DTRA), Co-Chair

Keynote: Fireside Chat: How Will AI and Machine Learning Play an Essential Part in the Future of RBQM?

Speakers: Demetris Zambas, Global Clinical Operations Leader, Pfizer Mayank Anand, VP and Global Head Data Strategy, Management and Centralised Monitoring; R&D India Lead, GSK Richard Young, VP, Strategy, Vault CDMS, Veeva

RBQM Best Practices Defined by Leading Industry Working Groups

Speakers: Linda Sullivan, Senior Advisor, Metrics & Performance Management WCG Nicole Stansbury, ACRO RBQM Working Group Member

Panel Discussion: Leveraging RBQM in Ways You Never Envisioned (Quality, Safety Review, etc.)

Speakers: Amit Gulwadi, Vice President- Head of Transformation, Alexion Blake Jensen, Quality and Compliance Executive, Adagio Jessica Jackson, Head of Clinical Operations, Galderma

Panel: The New Risk-Based Norm – What Transformative Outcomes (From the Last Two Years) Are Here to Stay?

Speakers: Katherine Taylor, Senior Director/Head Risk Evaluation and Adaptive Integrated Monitoring, Merck Olivia Feiro, Director, Risk Management and Analytics, CSL Behring Lynne Cesario, Senior Director, Risk Based Monitoring Program Lead, Pfizer