Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures

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...

Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures

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...

Guideline on good pharmacovigilance practices: Module XV – Safety communication

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,...

Guideline on good pharmacovigilance practices: Module X – Additional monitoring

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...

Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management

by Dr. Yashashwini Reddy | Jun 25, 2025

✅ GVP Module IX – Signal Management 📘 Purpose GVP Module IX provides comprehensive guidance for Marketing Authorisation Holders (MAHs) and regulatory authorities on how to perform signal management, which is a core part of pharmacovigilance. The goal is to ensure...