In summary, we believe that our work has the potential to strengthen the monitoring of the benefit-risk balance of medicines via the application of its experience and recommendations on the integration and presentation of benefit and risk data. The scope of our review of benefit-risk methodologies makes what we believe is a unique contribution to other efforts. As with all such endeavours, it is naturally limited by the extent of the work package's resources and the timing of the review. It has not been possible to examine the entire universe of benefit-risk approaches in detail, and new methodologies and evolutions of the frameworks are constantly emerging. We nevertheless hope that these recommendations serve as a valuable guide for readers who are new to the world of benefit-risk assessment, as they highlight key issues and considerations that are common to many approaches.