Risk benefit assessment is vital during the whole life cycle of products. All risks must be considered in the context of benefits. The underlying principles of assessment are the same whether pre- or post-marketing. For each medicine there is a balance between risk and benefit, but the perspective of different stakeholders (regulator, marketing authorisation holder, academic, patient, or prescriber) may vary. The Risk Benefit Assessment in Pharmacovigilance course enables delegates to explore the relationship between risk and benefit, plus review the integration of appropriate strategies within risk management plans.