by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XV – Safety Communication 📘 Purpose GVP Module XV provides guidance on how Marketing Authorization Holders (MAHs) and Regulatory Authorities should effectively communicate safety information about medicinal products to healthcare professionals, patients,...
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...
by Dr. Yashashwini Reddy | Jun 5, 2024
In this article, you are going to learn about the marketing authorization process in the EU region. European Medicines Agency (EMA) is the key regulator for regulating and monitoring medicinal products in the European Union. It has some expert committees which provide...
by Dr. Yashashwini Reddy | May 24, 2024
Drug Regulatory Authorities of Different Countries Drug regulatory authorities play a vital role in enabling the safety, efficacy, and quality of medicine we take. These authorities involve in overseeing the development, testing, approval, and monitoring of drugs...
