by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module IX – Signal Management 📘 Purpose GVP Module IX provides comprehensive guidance for Marketing Authorisation Holders (MAHs) and regulatory authorities on how to perform signal management, which is a core part of pharmacovigilance. The goal is to ensure...
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...
