#RBQMLive
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)
Speaker:
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
Speaker:
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
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

10:30 am - 11:30 am
RBQM Diversification: tSDV, tSDR, Dynamic Site Monitoring Strategies
Speaker:
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
Speaker:
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?
Speakers:
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
Speakers:
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.)
Speakers:
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?
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

*All times are in Eastern Standard Time (EST)