How to design a lean global PSUR and PBRER production process Designing a Lean Global PSUR and PBRER Production Process The production of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) is a critical component of pharmacovigilance and ensures compliance with regulatory requirements across global markets. The lean production of these reports not only facilitates timely submissions to regulatory authorities, but also offers an opportunity to enhance overall efficiency and quality. This article will provide a step-by-step tutorial for pharma professionals, clinical operations teams, and regulatory affairs professionals to design a lean global PSUR and PBRER production…