Back by popular demand, this short course will describe the myriad of factors that scientists and other stakeholders should consider when determining whether – and how – to use real world evidence (RWE) and select proper real world databases (RWD) to support regulatory submissions to the United States Food and Drug Administration (US FDA). This course will interpret and apply recent draft guidance documents related to RWE issued by the US FDA and use case studies – both successful and unsuccessful – to highlight key learnings. We will also review common biases and proper exposure definitions when conducting RWE studies.

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