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Real-World Evidence Conference

Translating Insights into Real-World Value.


Session 5: RWE Studies to Support Effectiveness in Regulatory Decision-making

Session Chair(s)

Jingyu (Julia)  Luan, PhD

Jingyu (Julia) Luan, PhD

  • Global Regulatory Affairs Director, BioPharmaceuticals R&D, CVRM
  • 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)

Charles  Lee, MBA, MS

Considerations in RWE Studies to Support Effectiveness in Regulatory Decision-making

Charles Lee, MBA, MS

  • Executive Regulatory Science Director
  • AstraZeneca, United States
LaRee  Tracy, PhD, MA

Successful and Unsuccessful Real-life Examples in RWE Studies to Support Effectiveness in Regulatory Decision-making

LaRee Tracy, PhD, MA

  • Director, Statistical Science, Medical & Real World Data Analytics
  • Otsuka Pharmaceutical Development and Commercialization, United States
Norman  Stockbridge, MD, PhD

Panel Discussion

Norman Stockbridge, MD, PhD

  • Director, Division of Cardiology and Nephrology, OND, CDER
  • FDA, United States
Shein-Chung  Chow, PhD

Panel Discussion

Shein-Chung Chow, PhD

  • Professor, Department of Biostatistics and Bioinformatics, School of Medicine
  • Duke University, United States
Yoshiaki  Uyama, PhD, RPh

Panel Discussion

Yoshiaki Uyama, PhD, RPh

  • Director, Office of Medical Informatics and Epidemiology
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan