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Session 2: Standardization of Real-World Data for Regulatory Submissions
Session Chair(s)
Brad Jordan, PhD
Associate Vice President, Regulatory Policy and Strategy
Eli Lilly and Company, 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
Speaker(s)
FDA Demonstration Projects
Motiur Rahman, PhD, MPharm, MS
FDA, United States
Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER
CDISC Standards and the Use of Real-World Data
Bess LeRoy, MPH
CDISC, United States
Head of Standards Development
Know Thy Data: Trusting RWD in Common Data Models for Regulatory Submissions
Mayur Saxena, PhD
Droice Labs, United States
Chief Executive Officer
Adapting Real-World Data (RWD) into CDISC Submission Standards: Challenges and Potential Solutions
James Browning, MPH
Amgen, United States
Director of Biostatistical Programming, Center for Observational Research