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.

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