Determining what are the true side effects of a medicinal product is the very core of patient safety work. Although the basic components of such assessments are common, the specific approaches may differ between practitioners in different parts of the pharmacovigilance network. In this session, representatives from industry and regulators, together with other experts, will present and discuss the broad aspects of causality assessment at group level, including; principles, thresholds, methodology and tools. Challenges and opportunities will also be covered as well as the role of the QPPV.
