Real-World Evidence:
What Researchers Must Know

image icon Duration: 1 hour
 

The role of real-world evidence (RWE) in regulatory, drug development, and clinical decision-making is rapidly expanding. The recent release of FDA’s real-world evidence program framework [December 2018] for evaluating the potential use of RWE in regulatory settings underscores the growing importance of RWE in research. Therefore, clinical trial and drug development professionals need to understand the sources of real-world data (RWD), potential uses of RWE, as well as the limitations and strengths of each approach. This webinar will describe the current state of RWE science and provide context for the regulatory and research implications of RWD and RWE.

Learning objectives:

  • Define real-world data/real-world evidence (RWD/RWE) and highlight current examples
  • Describe the features of regulatory-grade RWE and the current FDA RWE framework
  • Evaluate considerations for the future as RWE continues to evolve, including strengths and opportunities for development

Presented by:
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Rebecca Miksad

MD, MPH
Senior Medical Director
Flatiron Health



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Tim Stoddard
Senior Director, Quality & Regulatory Solutions
Flatiron Health

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