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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)
Motiur Rahman, PHD, MPHARM, MS
Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
FDA Demonstration Projects
Bess LeRoy, MPH
Head of Standards Development, CDISC, United States
CDISC Standards and the Use of Real-World Data
Mayur Saxena, PHD
Chief Executive Officer, Droice Labs, United States
Know Thy Data: Trusting RWD in Common Data Models for Regulatory Submissions
James Browning, MPH
Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
Adapting Real-World Data (RWD) into CDISC Submission Standards: Challenges and Potential Solutions