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THE US GRANT, a Luxury Collection Hotel, San Diego

Nov 10, 2022 7:00 AM - Nov 11, 2022 12:30 PM

326 Broadway, San Diego, CA 92101

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 7: Relevance and Reliability: The Role of Data Quality in Advancing the use of RWE for Regulatory Decision-Making

Session Chair(s)

Brad  Jordan, PhD

Brad Jordan, PhD

Associate Vice President, Regulatory Policy and Strategy

Eli Lilly and Company, United States

Yun  Lu, PhD, MS

Yun Lu, PhD, MS

Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER

FDA, United States

As the use of real-world data and real-world evidence to support regulatory decision-making increases, stakeholders are faced with identifying ways to better understand the underlying data sources and their evolution into a final analytic data set. This session will drill down into principles of data quality and seek to identify how stakeholders can work together to align on common terminology and approaches.

Learning Objective : At the end of this session, participants will be able to identify:
  • Understand recent lessons learned from regulatory guidance relating to data quality and data sources
  • Identify key aspects of real-world data that can have an impact on data quality and approaches to addressing these factors
  • Recognize approaches for assessing the relevance and reliability of real-world data


Jillian Mae Rockland, MPH

Fit for Purpose RWE: Considerations for Enabling Regulatory Use

Jillian Mae Rockland, MPH

Flatiron Health, United States

Director, Regulatory Strategy

Wei  Hua, PhD

Considerations of Epidemiologic Studies Using RWD for Regulatory Decision Making

Wei Hua, PhD

FDA, United States

Acting Deputy Director, Division of Epidemiology, OSE, CDER

Cathy W Critchlow, PhD, MSc

Transcelerate Biopharma’s Work on Practical Tools to Advance Fit-for-purpose Use of RWD in Regulatory Decision-making

Cathy W Critchlow, PhD, MSc

Amgen, Inc, United States

Vice President, R&D Data Strategy

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