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Session 5: RWE Studies to Support Effectiveness in Regulatory Decision-making
Session Chair(s)
Jingyu (Julia) Luan, PhD
Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
AstraZeneca, United States
The industry has been utilizing RWE studies to support pre- and post-market safety evaluation for many years. Regulators around the world have accepted RWE studies for safety decision-making and published various guidelines to guide the industry through this process. There are many successful experiences and examples that we can learn from. However, using RWE studies to support effectiveness decision-making is still an area under development. Even though all stake holders have been actively exploring this topic for some years, methodological, operational, technical, and regulatory challenges are still to be conquered. In this session, speakers and panelists from regulatory agencies, industry, and academia will discuss the general considerations in RWE studies to support effectiveness in regulatory decision-making. Both successful and unsuccessful cases studies will be shared.
Learning Objective : At the conclusion of this session, participants should be able to:
- Evaluatethe general considerations in RWE studies to support effectiveness in regulatory decision-making
- Recognize the key features of successful RWE studies acceptable to the regulators for effectiveness decision-making
- Identify the common issues that prevent RWE studies from supporting effectiveness
Speaker(s)
Considerations in RWE Studies to Support Effectiveness in Regulatory Decision-making
Charles Lee, MBA, MS
AstraZeneca, United States
Executive Regulatory Science Director
Successful and Unsuccessful Real-life Examples in RWE Studies to Support Effectiveness in Regulatory Decision-making
LaRee Tracy, PhD, MA
Otsuka Pharmaceutical Development and Commercialization, United States
Director, Statistical Science, Medical & Real World Data Analytics
Panel Discussion
Norman Stockbridge, MD, PhD
FDA, United States
Director, Division of Cardiology and Nephrology, OND, CDER
Panel Discussion
Shein-Chung Chow, PhD
Duke University, United States
Professor, Department of Biostatistics and Bioinformatics, School of Medicine
Panel Discussion
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director