The session will present the new structure of periodic safety update reports (PSURs)/periodic benefit-risk evaluation reports (PBRERs) according to the good pharmacovigilance practices (GVP)/ICH E2C(R2) guidance. Requirements and challenges for PSUR/PBRERs are outlined. Interference with RMPs and DSURs as well as practical advice for compilation is given. Examples for signal identification and risk evaluations are provided.