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Mar 29, 2022 10:00 AM - Mar 29, 2022 2:00 PM

(US Eastern Standard Time)

Design, Analysis and Evaluation of Confounding Bias Using RWD


Yuan-Li  Shen, DrPH

Yuan-Li Shen, DrPH

Division Director, Division of Biometrics IX, OB, OTS, CDER, FDA, United States

Yuan-Li is the Division Director of the Division of Biometrics IX, Office of Biostatistics, Office of Translational Science, CDER, FDA. The division is responsible for statistical reviews of regulatory submissions of hematology products including both benign and malignant products. She received a doctorate in Biostatistics from the University of North Carolina, Chapel Hill. She has over 25 years of combined experience in clinical trial setting across academia, pharmaceutical industry and FDA.

Yueqin  Zhao, PhD

Yueqin Zhao, PhD

Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States

Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.

Michele  Jonsson Funk, PhD, FISPE

Michele Jonsson Funk, PhD, FISPE

Associate Professor of Epidemiology; Director, Center for Pharmacoepidemiology, University of North Carolina at Chapel Hill, United States

Dr Jonsson Funk is an Associate Professor of Epidemiology and Director of the Center for Pharmacoepidemiology at UNC. Her research focuses on improving methods for the study of drug safety and effectiveness using real world data including understanding the impact of measurement error in studies using claims and EHR data, methods for generalizing treatment effects from clinical trials to real world populations, and evaluating treatment effect heterogeneity. As principal investigator for the DETECTe Demonstration Project, she led a team that evaluated the performance of approaches to assessing and addressing the threat of unmeasured confounding. Dr Jonsson Funk has 120 peer-reviewed publications spanning multiple therapeutic areas.

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