Agenda

#RBQMLive
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
Register
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 - 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?
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

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?
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)