Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

This session will continue discussion of the post-marketing setting in the EEA, with additional details on quality-assured pharmacovigilance systems, e.g., the Pharmacovigilance System Master File (PSMF), the role of the EU Qualified Person for Pharmacovigilance (QPPV), and EMA’s Medical Literature Monitoring (MLM) service.