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Sunday, June 14 • 9:00am - 12:30pm
SC21: #21: Real World Evidence: The Evolving Landscape of Regulators, Data and Integrated Use

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

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This short course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December, 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data. Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning Objectives

Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies;Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments;Recognize when RWE based approaches are of sufficient quality to enable decision making.


Speakers
avatar for Brian Bradbury

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States
Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA and Adjunct Professor of Epidemiology at the U of N Carolina School of Global Public Health. She leads the IQVIA Center for Advanced Evidence Generation. A fellow of both the International Society for Pharmacoepidemiology and... Read More →
avatar for Gillis Carrigan

Gillis Carrigan

Director, Center for Observational Research, Amgen, United States
Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number... Read More →
avatar for Matthew Reynolds

Matthew Reynolds

Vice President, Real World Evidence, IQVIA, United States
Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial