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,...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting...
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...
