PSUR roadmap: joint industry/assessor training

This joint industry and national competent authority assessors' training aims to achieve a common understanding of the role of periodic safety assessment reports (PSUR) in the product lifecycle and of the European Union (EU) PSUR single assessment. It is part of the PSUR roadmap activities and will identify key issues encountered by industry and regulators in the preparation of PSURs and share best practices on ways to address them. The webinar will be in the form of a question-and-answer (Q&A) session led by a joint panel of industry and regulators. It will cover the following topics described in the explanatory note to good pharmacovigilance practice (GVP) module VII and the PSUR Q&A for assessors: signals and close monitoring, safety specification, product information / reference safety information and use of summary tabulations. No prior registration is required. Please send questions on any topic to assessors and industry speakers to psurtraining@ema.europa.eu