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Sheraton Philadelphia Downtown Hotel

Oct 24, 2024 7:30 AM - Oct 25, 2024 4:10 PM

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 4: Real-World Data Standards for Regulatory Submissions: Exploring the Challenges, Solutions, and Potential Alternatives

Session Chair(s)

Diane  Gubernot, DrPH, MPH

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, MBA

RWE Standards: Reliability and Relevance

Dan Riskin, MD, MBA

Verantos, United States

Founder and Chief Executive Officer

Sarah  Ferko, MS, PMP

Submission Standards for RWD: Gaps, Limitations, and Recommendations

Sarah Ferko, MS, PMP

IBM, United States

Senior Managing Consultant, Artificial Intelligence & Analytics, U.S. Federal

James  Browning, MPH

Interpreting and Implementing RWD Standards – Challenges, Opportunities, and Open Questions

James Browning, MPH

Amgen, United States

Director of Biostatistical Programming, Center for Observational Research

G. Scott  Gordon, PhD

Panelist

G. Scott Gordon, PhD

FDA, United States

Senior Health Informatics Officer, OSP, CDER

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