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Real World Data Quality for Regulatory Decision-Making
Session Chair(s)
Rebecca Lipsitz, PhD
Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
AstraZeneca, United States
Demonstrating the quality of real world data (RWD) to support regulatory decision-making is a topic of great interest. This session will explore what is being done to demonstrate that RWD is of sufficient quality to support regulatory assertions.
Learning Objective : Describe how sponsors and data companies can demonstrate data quality, how FDA defines data quality, and how FDA reviewers assess real world evidence data quality; Discuss challenges with demonstrating data quality and what can be done to make advances in this area.
Speaker(s)
Evaluating Real World Data and Evidence
David Martin, MD, MPH
Moderna, United States
Vice President, Global Head RWE
Considerations for Selecting an Appropriate Real World Data Source
Brande Yaist, MHS
Eli Lilly and Company, United States
Senior Director, Global Patient Outcomes & Real World Evidence
Aspects of Data Relevancy and Quality for Regulatory-Grade Real World Data
David Thompson, PhD
Rubidoux Research LLC, United States
Founder and Principal Consultant
Real World Evidence Regulatory Grade Quality: Lessons from Recent Use Cases
Rebecca A Miksad, MD, MPH
Flatiron Health, United States
Senior Medical Director, Research Oncology
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