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Thursday, June 18 • 5:00pm - 6:00pm
#553 OD: ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data

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Component Type: Forum
Level: Intermediate

An number of on-going activities are examining real world data (RWD) and comparing it to data from randomized clinical trials in order to gauge whether the RWD are trustworthy and if they could be a substitute. Although useful to understand these measures, this approach ignores the unique contribution of RWD, particularly in the context of when it can be used to speed access to medical innovations, to understand comparative effectiveness and safety and the the implications of real-world adherence as well as characterize benefits and risks over longer periods of follow-up than are typical for most trials, particularly.

As regulators around the world become more interested in using RWD, current efforts in the US, Europe, and Japan will be discussed along with what they are requesting to provide comfort with the data methods and evidentiary requirements.

Learning Objectives

Discuss current efforts in the US, Europe, and Japan with using real world data to speed access to medical innovations, understand comparative effectiveness, and safety.

Chair

Nancy A. Dreyer, PhD, MPH, FISPE

Speaker

FDA Update
Peter P. Stein, MD

PMDA Update
Yoshiaki Uyama, PhD


Speakers
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum