The focus of this Information Day will be an update of the Agency’s ongoing activities on medicines’ risk management with the opportunity for an interactive platform to exchange experiences between Regulators and Industry.

A dedicated session will focus on the extensive revision of GVP module XVI, with special attention on criteria for selection, development, and implementation of various risk minimisation measures (RMMs) supporting the optimal use of a medicinal product in clinical practice, at any time during its lifecycle, and detailed guidance on principles and methods to evaluate their effectiveness.

An overview on the finalisation of GVP module product - or population-specific considerations III: pregnant and breastfeeding women – will also be presented.

Due to the current situation related to COVID-19 and possible revised deadlines for public consultations, the specific topics of this information day may be adjusted.