by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VIII – Post-Authorization Safety Studies (PASS) 📘 Purpose GVP Module VIII provides guidance on the design, conduct, and reporting of Post-Authorization Safety Studies (PASS) conducted by Marketing Authorization Holders (MAHs) after a product has been...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VII – Periodic Safety Update Report (PSUR) 📘 Purpose GVP Module VII provides guidance on the preparation, submission, and assessment of Periodic Safety Update Reports (PSURs) by Marketing Authorization Holders (MAHs).It ensures the continuous benefit-risk...
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...
by Dr. Yashashwini Reddy | May 6, 2025
Qualified Persons (QPs) play a critical role in the pharmaceutical industry by overseeing the safety, efficacy, and compliance of medicines. They are responsible for ensuring that pharmaceutical products meet stringent regulatory standards and are safe for public use....
