Risk-Benefit across the drug life-cycle: one size does not fit all

The presentation explores the nuanced and evolving nature of evaluating the risk-benefit balance of medicines throughout their development and use. Drawing from her experience as a former regulator at the Dutch Medicines Evaluation Board (MEB) and the European Medicines Agency (EMA), the presenter emphasizes that risk-benefit assessment is not a straightforward or binary process. It depends on multiple factors including the type of disease, drug characteristics, patient population, available treatment options, and how safety profiles are managed. The presentation highlights that both the FDA and EMA have policies that guide this complex evaluation, and that safety remains a priority throughout the drug life-cycle. It also underscores the importance of regulatory science—learning from data and performance—to improve transparency and dialogue between regulators and pharmaceutical stakeholders. The speaker advocates for context-sensitive approaches and continuous evolution in regulatory practices to better serve public health.