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Monday, June 20 • 1:30pm - 2:30pm
#118: Real-World Evidence Frameworks Across the World: Three International Perspectives

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-519-L04-P ; CME 1.00; RN 1.00

In this session, three global regulatory agencies will present their frameworks for the use of Real World Evidence. The focus will be on the types of questions that can be answered now, as well as a view of the opportunities in the future.

Learning Objectives

Describe the similarities and differences between global regulatory frameworks for real-world evidence (RWE); Discuss how regulators are using RWE and how they will use it in the future, including the types of regulatory procedures it can support.

Chair

Andrew Thomson, PhD, MA, MS

Speaker

Moderator
Rachele Hendricks-Sturrup, DrSc, MA, MSc

FDA Perspective
John Concato, MD, MPH, MS

Health Canada Perspective
Melissa Kampman, PhD, MS


Speakers
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States
Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator... Read More →
avatar for Melissa Kampman

Melissa Kampman

Manager and Senior Epidemiologist, Marketed Health Products Directorate, Health Canada, Canada
Melissa Kampman is a manager and senior epidemiologist at Health Canada. She holds an MSc in Chemical and Environmental Toxicology and a PhD in Population Health. Her training is in pharmacoepidemiology and pharmacovigilance. Her main areas of interest are population health, study... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →

Monday June 20, 2022 1:30pm - 2:30pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum