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Session 10: The Future of RWD and RWE
Session Chair(s)
Charles Lee, MBA, MS
Executive Regulatory Science Director
AstraZeneca, United States
In the past two days, this conference has reviewed the proliferation of real world data sources and technological advances that have spurred innovative uses of real world data and real world evidence by sponsors in product development and regulators in product evaluations. In this session, we discuss the future trends for RWE. Potential topics may include:
- The use of RWE/RWD to address clinical post-marketing commitments issued by the US FDA for novel and supplemental NDA/BLA approvals in oncology
- FDA’s framework for advancing RWE programs. What comes next?
- The concept of synthetic data, their applications, and challenges to adoption
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize trends in clinical post-marketing commitments (PMC) and requirements (PMR) issued by US FDA in oncology and how RWE can be applied
- Understand FDA’s current framework for advancing RWE and identify areas for further development
- Describe the concept of synthetic data and assess opportunities for their application
Speaker(s)
Regulatory Trends in Oncology Post-Marketing Commitments and Requirements issued by the US Food and Drug Administration
Adam Shiell, PharmD
Flatiron Health, United States
Global Regulatory Strategist
Beyond the Cures Act: What's Next for FDA's RWE Program
Thomas Brown, MD, MBA
Syapse, United States
Chief Medical Officer
Synthetic Data for RWD
Lucy Mosquera, MSc
Replica Analytics, Canada
Senior Director, Data Science
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