1st hour: Source of RWD: Fitness for Purpose
• Identifying RWD: what to look at?
• Ascertaining exposure, outcome & covariates
• Assessing validation studies

2nd hour: Causal Inference in RWE Context
• Draw your assumptions: tools to identify potential confounders
• Selection and measurement bias in studies using RWD
• Successful RWE included in drug evaluation.