by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VI – Addendum I: Duplicate Management of Suspected Adverse Reaction Reports 🔹 Purpose This Addendum to GVP Module VI provides guidance on how Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs) should manage duplicate...
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 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 23, 2025
🔹 Introduction Drug development is a complex, multi-phase process aimed at discovering, designing, testing, and bringing new therapeutic products to market. Ensuring the safety and efficacy of these medicines is not a one-time task—it continues long after approval....
by Dr. Yashashwini Reddy | Jun 18, 2025
Here’s a complete view of pharmacovigilance—a structured, end‑to‑end journey that ensures drug safety from lab to real-world use: 1. Definition & Scope Pharmacovigilance (PV) is the science and set of processes for detecting, assessing, understanding, and...
