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Thursday, June 23 • 10:00am - 11:00am
#410: Addressing Gaps in the Use of Real-World Evidence for Regulatory Decision-Making

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-653-L04-P ; CME 1.00; RN 1.00

The use of real-world evidence (RWE) for regulatory decision-making is a rapidly evolving space. Providers of RWE and regulators will describe the current state, identify current gaps in practice and policy, and identify key advancements needed to further the use of RWE.

Learning Objectives

Describe the current state for the use of real-world evidence (RWE) in regulatory decision-making and gain a general knowledge with respect to current health authority guidance; Discuss the current gaps in the use of RWE for regulatory use and gain perspective on the path forward; Identify key policy issues that need to be addressed in order to further advance the use of RWE in regulatory decision-making.


Brad Jordan, PhD


Alissa M Winzeler-Cotton, PhD

Bart Barefoot, JD

FDA Update
Paul Kluetz, MD

MHRA Update
David Brown, MSc

EMA Update
Andrew Thomson, PhD, MA, MS

avatar for Bart Barefoot

Bart Barefoot

Senior Director, European Regulatory Policy, GlaxoSmithKline, United Kingdom
Bart Barefoot, JD, is Senior Director of European Regulatory Policy at GlaxoSmithKline. He formerly served as GSK's global head of RWE policy development and engagement, where he led the company's efforts to advance the appropriate use of RWE in health care decision-making. He served... Read More →

David Brown

Head of Statistics Team, Healthcare, Quality & Access, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
David Brown is the head of the Statistics team at the MHRA. He has over 20 years’ experience as a statistical assessor at the MHRA, and prior to Brexit was a member of both the biostatistics working party and scientific advice working party at the EMA. He was part of the group that... Read More →
avatar for Brad Jordan

Brad Jordan

Senior Director, Head of Regulatory Affairs Policy, Flatiron Health, United States
Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology... Read More →
avatar for Paul Kluetz

Paul Kluetz

Deputy Director, Oncology Center of Excellence, OC, FDA, United States
Paul Kluetz is a medical oncologist and the Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. His interests include defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval, and opportunities... 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 →

Alissa Winzeler-Cotton

Senior Vice President for Strategy, Research, and Medicine, Synapse, United States

Alissa Winzeler-Cotton

Senior Vice President for Strategy, Research, and Medicine, Syapse, United States
Alissa Winzeler-Cotton, Ph.D., is the Senior Vice President of Strategy, Research, and Medicine at Syapse, where she helps to shape the company’s strategic priorities across multiple dimensions. In this role, she has served as one of Syapse’s representatives in developing the... Read More →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 187 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