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Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Session Chair(s)
Jeanette Towles, MA
President and CEO
Synterex, Inc., United States
This session delves into the latest guidance on real-world data (RWD) and real-world evidence (RWE), offers insights from case studies in which such data were critical for regulatory decisions, and discusses how to prepare the next generation of medical writers for this complex landscape.
Learning Objective : Analyze the FDA’s current stance and guidance on real-world data (RWD) and real-world evidence (RWE) in regulatory submissions; Compare real-world applications of RWD and RWE, showcased through several case studies; Outline educational strategies for equipping future regulatory and medical writers with the skills and understanding needed to effectively incorporate RWD and RWE into documentation.
Speaker(s)
Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Clarence L Young, MD
Propharma, United States
Senior Vice-President, Clinical, US Regulatory Sciences
Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Tina Schlecht, PharmD, MBA
RxE2, United States
Chief Pharmacy Officer
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