This is an introductory course on pharmacoepidemiology. How the principles of modern epidemiology methods are applied to evaluate safety, effectiveness, and utilization patterns of medical products (drugs, vaccines, and medical devices) will be discussed. Examples of descriptive epidemiology studies, cohort studies, case control studies, intervention studies, and meta-analysis will be drawn from recent literature to illustrate the application of relevant methods and the challenges in post-marketing medical product assessment. Perspectives from research institutions, medical product manufacturers, and regulatory agencies will be presented. Related topics, including therapeutic risk management, safety signal detection and refinement, data sources and ethics considerations, will be discussed. Advanced methodology, such as that utilized to address confounding by indication and misclassification will be briefly introduced.