27th Annual EuroMeeting

The benefit/risk profile of a medicinal product must be favorable to gain and maintain marketing authorisation. From a pragmatic view, however, different approaches and proportionality are needed to assess and manage the benefit-risk balance across a product’s lifecycle in a resource-appropriate manner. This session will address practical aspects of benefit-risk management from First-In-Human studies through late-cycle product maturation. Different lines of evidence, challenges in their evaluation, and triggers for PASS and PAES will be discussed in a pragmatic context, considering both patient safety and the changing realities of data across a product’s lifecycle.