2022 Agenda
Day One Sessions
Day Two Sessions
08:00 - 08:45 am
Keynote: How the Current RBQM Landscape Will Reinforce the Way We Improve Efficiencies and Add Value (Research Study Findings)
Speaker: Ken Getz, Professor, Tufts Center for the Study of Drug Development
08:45 - 09:30 am
Compliance is Key: ICH E6 (R3) & E8 (R1) Guidance Update
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 - 12:00 pm
RBQM Diversification: tSDV, tSDR, Dynamic Site Monitoring Strategies
Lesley Lardino, Senior Director, Data Management and Central Monitoring, Astellas
12:00 - 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
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 Centralised Monitoring; R&D India Lead, GSK

Moderator: John Hall, Senior Vice President EU and AsiaPac, CluePoints

09:15 - 10:15 am
Risk-Based Data Review & Medical Coding
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
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)