by Dr. Yashashwini Reddy | Jun 26, 2025
📘 Pharmacovigilance System Master File (PSMF) ✅ What is PSMF? The Pharmacovigilance System Master File (PSMF) is a legal, detailed, and continuously maintained document that describes the pharmacovigilance (PV) system used by a Marketing Authorization Holder...
by Dr. Yashashwini Reddy | Jun 24, 2025
🗂️ GVP Module II: Pharmacovigilance System Master File (PSMF) 🔹 Purpose GVP Module II provides guidance on the structure, content, maintenance, and location of the Pharmacovigilance System Master File (PSMF), a key document required for all Marketing Authorization...
by Dr. Yashashwini Reddy | Jun 24, 2025
The Guideline on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems is a foundational document developed by the European Medicines Agency (EMA) to ensure the effective monitoring of medicinal product safety within the...
