*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
This Short Course will be offering in a virtual format only
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) to support regulatory submissions to global regulatory agencies. This course will interpret and apply recent draft guidance documents related to RWE issued by the various regulatory agencies and use case studies – both successful and unsuccessful – to highlight key learnings.
- Identify potential use cases for RWD and RWE in regulatory submissions
- Analyze the impact of study design and methodological approaches in specific use cases on how RWD and RWE may be received by regulatory agencies
- Identify factors related data relevance and reliability that constitute quality RWD and RWE for regulatory submissions
- Recognize whether hypothetical patient-level RWD would be considered sufficient for regulatory purposes, and how this decision might be made using guidance documents and other relevant information