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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 2: Standardization of Real-World Data for Regulatory Submissions

Session Chair(s)

Brad  Jordan, PhD

Brad Jordan, PhD

Senior Director, Head of Regulatory Affairs Policy

Flatiron Health, United States

This session will examine the use of data standards for the formatting and submission of data sets using real-world data. Speakers will address the use of various data standards and will speak to the utility of these various standards to facilitate the analysis and submission of real-world data. A short panel discussion will follow.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize the importance of common data models for real-world data
  • Identify various data standards used for the analysis and submission of real-world data
  • Discuss challenges associated with application of different data standards


Motiur  Rahman, PhD, MPharm, MS

FDA Demonstration Projects: Motiur Rahman, PhD, MPharm, MS

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER

FDA, United States

Bess  LeRoy, MPH

CDISC Standards and the Use of Real-World Data : Bess LeRoy, MPH

Head of Standards Development

CDISC, United States

Mayur  Saxena, PhD

Know Thy Data: Trusting RWD in Common Data Models for Regulatory Submissions: Mayur Saxena, PhD


Droice Labs, United States

James  Browning, MPH

Adapting Real-World Data (RWD) into CDISC Submission Standards: Challenges and Potential Solutions: James Browning, MPH

Director of Biostatistical Programming, Center for Observational Research

Amgen, United States

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