Roles and Responsibilities of EU and UK QPPV

This document provides insights into the QPPV role, covering its purpose, regulatory framework, and responsibilities including PV compliance oversight, safety database management, and acting as a regulatory contact. Key operational processes such as nomination, deputizing, and ensuring 24/7 system availability are discussed. It highlights delegation, collaboration, and supervision in global safety management and details documentation requirements like PSMF contact information, regulatory...