The Essential Role of the EU QPPV in Pharmacovigilance

📢 DDReg Knowledge Capsule – Episode [16]Role of the Qualified Person Responsible for Pharmacovigilance (QPPV) in the European Union (EU). It clarifies that the QPPV services is a legally mandated strategic leader for every Marketing Authorisation Holder, continuously ensuring the safety and benefit-risk profile of marketed medicines in line with EU pharmacovigilance (PV) legislation. The article details the QPPV’s five core responsibilities, including oversight of the PV system, maintenance of the Pharmacovigilance System Master File (PSMF), and acting as the primary regulatory interface for safety matters.