EU regulations and Good Pharmacovigilance Practices (GVPs) require marketing authorisation holders to continuously monitor the benefits and risks of their medicines.
The benefit-risk assessment process, which requires pharmacovigilance expertise, challenges departments to meet critical integrated benefit-risk assessment requirements. Stakeholders may have different perspectives, including regulators, marketing authorisation holders, patients or prescribers.
This course aims to provide knowledge and understanding of the concepts and principles of benefit-risk assessment and to promote critical analysis of data for risk assessment.
It covers both qualitative and basic quantitative methods for benefit-risk assessment, with an emphasis on practical applications in decision making.
Special attention will be given to understanding the motivations and backgrounds of different stakeholders, as well as actions to minimise risks associated with medicines.