by Dr. Yashashwini Reddy | Sep 23, 2025
Case Study: Pharmacovigilance Signal Detection – Vioxx (Rofecoxib) Background Drug: Rofecoxib (Brand name: Vioxx) Company: Merck & Co. Indication: Relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, and acute pain. Launch: 1999 Mechanism:...
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 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...
by Dr. Yashashwini Reddy | Jun 10, 2024
Methods in Pharmacovigilance, this article will give you an overview of the pharmacovigilance methods and the concepts involved in it. Definition of Pharmacovigilance as per WHO: science and activities relating to detecting, assessing, understanding, and preventing...
