Within the European regulatory framework, pharmacovigilance is essential to ensure patient safety. At the center of this system stands the QPPV (Qualified Person for Pharmacovigilance) — a critical role for any Marketing Authorisation Holder (MAH) in Europe.
👤 What is a QPPV?
The QPPV is the legally responsible person for a company’s pharmacovigilance system. Their main responsibility is to ensure compliance with all EU pharmacovigilance requirements, in line with the EMA Good Pharmacovigilance Practices (GVP).
🔍 Main Responsibilities of the QPPV
The QPPV:
- 🧠 Oversees the entire pharmacovigilance system
- 📊 Ensures collection, evaluation, and reporting of adverse events
- 📁 Maintains the Pharmacovigilance System Master File (PSMF)
- 🕒 Is available 24/7 for health authorities
- 🤝 Acts as the main contact with regulatory authorities
- 🎓 Ensures continuous PV training within the organization
🌍 A Strategic Role in Europe
The QPPV must be located within the European Economic Area (EEA) and plays a crucial role during inspections. They are the key interface between the company and health authorities.
👉 In short, the QPPV is not just a regulatory requirement — they are a cornerstone of patient safety and regulatory compliance 💙
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