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Sunday, June 24 • 8:30am - 12:00pm
#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?

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Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-18-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference short courses.|

Real world evidence (RWE) has the potential to compliment and extend the safety and effectiveness knowledge of drugs gained from RCTs. This session will discuss key study design principles to guide evaluation of RWE using studies focused on cardiovascular safety assessments.

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Who should attend?

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

Learning Objectives

At the conclusion of this course, participants should be able to:
  • 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 Alan Brookhart

Alan Brookhart

Professor, Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill
M. Alan Brookhart, Ph.D., is a Professor of Epidemiology at the UNC Gillings School of Global Public Health University of North Carolina at Chapel Hill. Dr. Brookhart’s research has focused on the development and application of innovative epidemiologic study designs, statistical... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation, IQVIA
Nancy Dreyer is the chief scientific officer and global chief of scientific affairs for IQVIA Real-World & Analytic Solutions. She leads the Center for Advanced Evidence Generation, focusing on the use of real-world evidence for regulators, payers, clinicians, and patients using minimally... Read More →
avatar for Mary Jane Geiger

Mary Jane Geiger

Vice President and TA Lead, Drug Development Services, ICON
MJ Geiger is VP & CV lead for ICON’s Drug Development Services providing scientific, operational and therapeutic expertise spanning the development continuum from concept through development to post-approval activities. She is involved in the Cardiac Safety Research Consortium... Read More →
NS

Norman Stockbridge

Director, Division of Cardiovascular and Renal Products, OND, CDER, FDA
Norman Stockbridge received his MD and PhD (Physiology) from Duke University. He has been a part of the FDA/CDER Division of Cardiovascular and Renal Products since 1991, serving as Division Director since 2004.


Sunday June 24, 2018 8:30am - 12:00pm
Room 157C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA