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#204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence
Tuesday June 17, 2025 8:30am - 9:30am EDT
143ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-554-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

James Browning, MPH

Speaker

Healthcare Organization Research Technology Perspective
Christopher Herrick, MBA

Traceability - Tools & Implementation Perspective
Anand Shroff, MBA, MS

Regulator Perspective
Marie C. Bradley, PhD, MPH, MPharm

Epidemiologist/Observational Researcher Perspective
Nancy Dreyer, PhD, MPH, FISPE


Speakers
MB

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as program lead for the FDA Advancing Real... Read More →
avatar for James Browning

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States
Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise... Read More →
avatar for Christopher Herrick

Christopher Herrick

VP of Research Systems and Technology, Mass General Brigham (MGB), United States
Christopher Herrick is the Vice President of Research Technology at Mass General Brigham, where he leads the strategic development of data and technology platforms that support clinical research across one of the nation’s largest academic health systems. He co-leads the Hospital... Read More →
AS

Anand Shroff

President, Verantos, United States
Anand Shroff is a co-founder and President of Verantos, a company which specializes in rich and reliable RWD and high-validity RWE using AI. Previously, he was one of the founders of Health Fidelity (acquired by Edifecs/Francisco Partners), which focused on identifying and quantifying... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   03: Data-Tech, Forum

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