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Real World Data Quality for Regulatory Decision-Making
Session Chair(s)
Rebecca Lipsitz, PhD
Sr. Director, Regulatory Policy & Intelligence, 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)
David Martin, MD, MPH
Vice President, Head, PCO Center of Excellence, Novartis, United States
Evaluating Real World Data and Evidence
Brande Yaist, MHS
Senior Director, Global Patient Outcomes & Real World Evidence, Eli Lilly and Company, United States
Considerations for Selecting an Appropriate Real World Data Source
David Thompson, PhD
Founder and Principal Consultant, Rubidoux Research LLC, United States
Aspects of Data Relevancy and Quality for Regulatory-Grade Real World Data
Rebecca A Miksad, MD, MPH
Senior Medical Director, Research Oncology, Flatiron Health, United States
Real World Evidence Regulatory Grade Quality: Lessons from Recent Use Cases
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