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 This course will interpret and apply recent draft guidance documents related to RWE issued by the US FDA and use case studies – both successful and unsuccessful – to highlight key learnings.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.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording! Note: You do not need to register for the full RWE Conference to attend this Virtual Short Course.