This fireside chat will examine the intent and practical impact of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) M14 guideline on noninterventional safety studies using real‑world data. Panelists will discuss key principles such as fit‑for‑use data, stepwise study design, transparency, and early regulatory engagement, as well as the benefits and challenges of global harmonization. The webinar will also consider how the ICH M14 guidelines lays the groundwork for future real‑world evidence guidance.