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#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead)
Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-530-L04-P; CME 1.00; RN 1.00

This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.

Learning Objectives

Explain how current CDISC standards set the foundation for RWD/RWE submissions; Discuss evolving data standards, including Dataset-JSON and HL7 FHIR, focusing on how they may complement or extend CDISC; Identify actions sponsors can take now to prepare for evolving regulatory data standards.

Chair

James Browning, MPH

Speaker

Panelist
Chris Decker, MS

Panelist
Anne-Marie Meyer, MS


Speakers
avatar for James Browning

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 16 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
avatar for Chris Decker

Chris Decker

President and CEO, CDISC, United States
Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →
AM

Anne-Marie Meyer

Advisor, Lind AI, Switzerland
Dr. Meyer is Vice President of Healthcare Consulting at acc solutions and advisor to LindAI. As Adjunct Associate Professor at UNC Chapel Hill, she has bridged epidemiology and health informatics for 20+ years. At Lineberger Cancer Center, she built a secure data platform linking... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Evidence Innovation
  • Interest Area Data Management & Data Standards,Biostatistics
  • Tags Forum

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