The proactive planning of risk minimisation measures (RMMs) in the context of optimizing the benefit-risk profiles of medicinal product is a challenging task. RMMs should be commensurate to the risk in relation to the clinical benefit of the product and should work for the intended patient population without adding undue burden on the healthcare systems.

After the recent updates to GVP XVI, it’s clear that they should also allow for rapid evaluation of their effectiveness to enable evidence-based adaptation to achieve their objectives or align to a changing healthcare environment, if and when necessary.

In this course, we will share experiences and challenges in designing, implementing, and evaluating RMMs in different regulatory settings and different therapeutic areas, as well as presenting an outlook on what may be the next generation of RMM tools.