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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)
Healthcare Organization Research Technology Perspective
Christopher Herrick, MBA
Mass General Brigham (MGB), United States
VP of Research Systems and Technology
Traceability - Tools & Implementation Perspective
Anand Shroff, MBA, MS
Verantos, United States
President
Regulator Perspective
Marie Bradley, PHD, MPH, MPHARM
FDA, United States
Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER
Epidemiologist/Observational Researcher Perspective
Nancy A Dreyer, PHD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
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