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Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes


Session 1: Regulatory Frameworks for Real World Evidence

Session Chair(s)

Jacqueline A. Corrigan-Curay, JD, MD

Jacqueline A. Corrigan-Curay, JD, MD

  • Director, Office of Medical Policy, CDER
  • FDA, United States
This session will be an update on FDA’s RWE program including a review of top priorities, program initiatives, and demonstration programs and updates from EMA on their RWE initiatives.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Define the elements of FDA’s RWE framework
  • Describe two demonstration projects and their relevance to the FDA’s program
  • Discuss current harmonization among regulatory approaches

Speaker(s)

Jacqueline A. Corrigan-Curay, JD, MD

Speaker

Jacqueline A. Corrigan-Curay, JD, MD

  • Director, Office of Medical Policy, CDER
  • FDA, United States
Andrew  Raven, MSc

Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making

Andrew Raven, MSc

  • Manager for Biostatistics and Epidemiology Unit, HPFB
  • Health Canada, Canada
Xavier  Kurz, MD, PhD, MSc

Use of Real World Evidence for Regulatory Decision Making: Perspectives from the European Medicines Agency (Remote Presentation)

Xavier Kurz, MD, PhD, MSc

  • Head of Data Analytics workstream
  • European Medicines Agency, Netherlands

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Preconference Short Course

Introduction to Real World Data for Data Geeks


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