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Real-World Evidence – The Evolving Landscape for Regulators, Data, and Integrated Use

This on-demand course provides an overview of how real-world evidence is being used today for evidence generation in major markets.

Overview

This on-demand course provides 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, but the approaches described here are useful for health technology assessments for payers. Following the major points from recently released guidance documents from around the world, the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status when real-world studies will be sufficient to meet regulatory evidence requirements will be reviewed and discussed.

This on-demand training course takes an average of 3 hours to complete. Learners have access to the course for one year from the date of purchase.

What you will learn

    • The evolving regulatory landscape
    • Evolving real-world data: it's uses and determining when it is "fit for purpose"
    • External comparator analyses
    • Considering real-world evidence (RWE) in the context of an integrated package of evidence

Who should attend?

  • This course is designed for professionals involved in or interested in learning about:

    • Real-world evidence
    • Real-world data
    • Epidemiology
    • Clinical research
    • Regulatory
    • Technology development
    • Learning objectives

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

        • Recognize how regulators are using RWE for regulatory decision support
        • Identify the concept of RWE being “fit for purpose” including the importance of relevant data and methodologic rigor
        • Determine how RWE can be assembled and integrated to generate a compelling message

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