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Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence
Session Chair(s)
James Browning, MPH
Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
This session will engage an expert panel in a discussion on traceability of RWD. Panelists will describe challenges and discuss potential solutions to maintain and document traceability of RWD used in regulatory submissions.
Learning Objective : Describe the inherent challenges in maintaining and documenting the traceability of Real-World Data (RWD) for regulatory purposes; Discuss potential solutions, including new and existing technologies, to enhance RWD traceability; Evaluate the strengths and weaknesses of various approaches to RWD traceability in a regulatory context.
Speaker(s)
Christopher Herrick, MBA
VP of Research Systems and Technology, Mass General Brigham (MGB), United States
Healthcare Organization Research Technology Perspective
Anand Shroff, MBA, MS
President, Verantos, United States
Traceability - Tools & Implementation Perspective
Marie Bradley, MPH
Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States
Regulator Perspective
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Epidemiologist/Observational Researcher Perspective
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