Back to Agenda
Session 4: Real-World Data Standards for Regulatory Submissions: Exploring the Challenges, Solutions, and Potential Alternatives
Session Chair(s)
Diane Gubernot, DrPH, MPH
Epidemiologist, US FDA, United States
In this session panelists will share new developments in real-world data (RWD) standards for regulatory submissions, including: updates from sponsors, data providers, standards development groups, validation organizations, and the FDA. Topics will include challenges, solutions, and potential alternatives to data standards from FDA’s Catalog and assess other common data models that could be considered as additions.
Learning Objective : - Explain the importance of real-world data standards for regulatory submissions and generally why existing standards used for clinical trials is not currently a perfect fit
- List potential RWD alternatives to existing regulatory data standards along with pros and cons of each
- Describe challenges faced when developing and utilizing standards for Real-World Data
Speaker(s)
Dan Riskin, MD
Founder and Chief Executive Officer, Verantos, United States
RWE Standards: Reliability and Relevance
Sarah Ferko, MS, PMP
Senior Managing Consultant, Artificial Intelligence & Analytics, U.S. Federal, IBM, United States
Submission Standards for RWD: Gaps, Limitations, and Recommendations
James Browning, MPH
Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
Interpreting and Implementing RWD Standards – Challenges, Opportunities, and Open Questions
G. Scott Gordon, PhD
Senior Health Informatics Officer, OSP, CDER, FDA, United States
Panelist
Have an account?