by Dr. Yashashwini Reddy | Jun 30, 2025
🧪Evaluating the Potential Risks and Benefits of the Research for Participants 🔍 1. What is Risk-Benefit Assessment in Clinical Research? Risk-Benefit Assessment is a critical ethical and scientific evaluation process in which researchers, sponsors, and ethics...
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...
