by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting...
by Dr. Yashashwini Reddy | Jun 25, 2025
🔹 GVP Module VI – Collection, Management, and Submission of Reports of Suspected Adverse Reactions to Medicinal Products 📘 Objective: To guide Marketing Authorization Holders (MAHs), national competent authorities (NCAs), and sponsors on how to: Collect Manage...
by Dr. Yashashwini Reddy | Jun 24, 2025
GVP Module IV – Pharmacovigilance Audits 🔹 Purpose GVP Module IV provides guidance on the planning, conduct, reporting, and follow-up of audits of pharmacovigilance (PV) systems, including the role of quality assurance in maintaining PV compliance. 🔹 Key...
by Dr. Yashashwini Reddy | Jun 24, 2025
🕵️♀️ GVP Module III – Pharmacovigilance Inspections 🔹 Purpose GVP Module III provides guidance on how pharmacovigilance (PV) inspections are conducted by regulatory authorities in the EU to ensure compliance with PV obligations and to safeguard public health. 🔹 Key...
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...
