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Overview

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.

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

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