Short Course requires Pre-Registration and is an additional fee.

In recent years, we have seen increasing interest in real world evidence for regulatory decision making (eg FDA RWE framework, ICH E8 R1) while promoting clearly defined scientific questions and causal assessment (eg ICH E9 R1). These interests are particularly tangible in aggregated safety evaluation from randomized clinical trials (RCTs) and real-world evidence (RWE). In this short course, we will review the evolving landscape and describe key components of safety signaling and causal assessment. We will summarize design considerations for pragmatic and observational trials for safety evaluation and highlight safety analytical approaches with illustrative examples.