by Dr. Yashashwini Reddy | Jun 26, 2025
🧪 Pharmacovigilance in Clinical Trials ✅ What Is It? Pharmacovigilance in clinical trials refers to the detection, assessment, reporting, and prevention of adverse events (AEs) or adverse drug reactions (ADRs) during the clinical development phase of...
by Dr. Yashashwini Reddy | Jun 26, 2025
Here is a comprehensive list and explanation of ICH Guidelines related to Pharmacovigilance, which aim to harmonize safety monitoring practices across regulatory regions: ✅ Core ICH Guidelines for Pharmacovigilance Code Title Focus Area E2A Clinical Safety Data...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XVI – Addendum II: Methods for Evaluating the Effectiveness of Risk Minimization Measures (RMMs) 📘 Purpose This addendum to GVP Module XVI provides specific methodologies and practical guidance for evaluating the effectiveness of risk minimization...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XVI – Risk Minimization Measures (RMMs) 📘 Purpose GVP Module XVI provides detailed guidance on the planning, implementation, evaluation, and effectiveness of risk minimization measures (RMMs) that are necessary to ensure safe use of medicinal products in...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XV – Safety Communication 📘 Purpose GVP Module XV provides guidance on how Marketing Authorization Holders (MAHs) and Regulatory Authorities should effectively communicate safety information about medicinal products to healthcare professionals, patients,...
