9th European Forum for QPPVs

Labelling is a legal requirement within the EU and a pillar among risk management tools. The RSI should properly communicate the efficacy and safety characteristics of a medicinal product, thus allowing HCPs and patients to appropriately select and use them. The continuous and timely maintenance of the RSI safety content, as the creation of processes and procedures related to its management, are MAH’s responsibilities subjects to Health Authorities’ evaluation – of which the EU QPPV’s knowledge is often checked at inspection. This session will review the main concepts associated with the description, selection and maintenance of an RSI and will address practical challenges associated with these activities. Any potential differences deriving from features of the various medicinal products (e.g. type of chemical entity category, registration status etc) will be discussed by various QPPVs.