The 2010 European Pharmacovigilance Legislation has converted many of the concepts and approaches of pharmacovigilance into practical applications. Whilst refinement of this process continues, it already provides a system that promotes patient safety whilst remaining proportionate. This theme reviews the important learnings in pharmacovigilance to date, and what role it plays in stimulating innovation. It will examine which principles and technologies are driving change. How should these new insights and new approaches affect the way we consider risk – benefit? Should risk – benefit be applied in the same way for new and established treatments.