2022 Agenda
Day One Sessions
Day Two Sessions
08:00 - 08:45 am
Keynote: How the Evolving RBQM Landscape Will Reinforce the Way We Improve Efficiencies and Add Value (Research Study Findings)
Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development
08:45 - 09:30 am
Compliance is Key: ICH E6 (R3) & E8 (R1) Guidance Update
Jonathan Rowe, Principal, Head of R&D Quality, Operations and Risk Management at ZS
09:30 - 10:30 am
Panel: Interpreting QTLs Through the Lens of Where They Are Today and Where They Are Evolving
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

10:30 am - 11:30 am
RBQM Diversification: tSDV, tSDR, Dynamic Site Monitoring Strategies
Lesley Lardino, Senior Director, Data Management and Central Monitoring, Astellas
Peter Stokman, Business Lead Clinical Data Reporting & Visualization Environment - Bayer
Jacqueline Gough
11:30 am - 1:00 pm
Panel Discussion: Understanding the Risks of Decentralized Trials as Sources of Data Increase and How to Plan for Success Proactively
Cris McDavid, Associate Director, Global Clinical Operations, RBQM, Parexel
Joseph Dustin, Vice President of Product Strategy for eCOA at Medable
Craig H. Lipset, Managing Partner, Clinical Innovation Partners
08:00 - 09:15 am
Keynote: Fireside Chat: How Will AI and Machine Learning Play an Essential Part in the Future of RBQM?
Demetris Zambas, Global Clinical Operations Leader, Pfizer
Mayank Anand, VP and Global Head Data Strategy, Management and Centralized Monitoring; R&D India Lead, GSK
Richard Young, VP, Strategy, Vault CDMS, Veeva Systems
09:15 - 10:15 am
RBQM Best Practices Defined by Leading Industry Working Groups
Linda Sullivan, Senior Advisor, Metrics & Performance Management WCG
Nicole Stansbury, ACRO RBQM Working Group Member
10:15 - 11:30 am
Panel Discussion: Leveraging RBQM in Ways You Never Envisioned (Quality, Safety Review, etc.)
Amit Gulwadi, Vice President- Head of Transformation, Alexion
Blake Jensen, Quality and Compliance Executive, Adagio
Jessica Jackson, Head of Clinical Operations, Galderma
11:30 am - 01:00 pm
Panel: The New Risk-Based Norm – What Transformative Outcomes (From the Last Two Years) Are Here to Stay?
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

*All times are in Eastern Standard Time (EST)