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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
Associate Vice President, Regulatory Policy and Strategy
Eli Lilly and Company, United States
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
Speaker(s)
Fit for Purpose RWE: Considerations for Enabling Regulatory Use
Jillian Mae Rockland, MPH
Flatiron Health, United States
Director, Regulatory Strategy
Considerations of Epidemiologic Studies Using RWD for Regulatory Decision Making
Wei Hua, PhD
FDA, United States
Acting Deputy Director, Division of Epidemiology, OSE, CDER
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