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Recent Posts
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures
✅ GVP Module XVI – Addendum II: Methods for Evaluating the Effectiveness of Risk Minimization Measures (RMMs) 📘 Purpose This...
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures
✅ GVP Module XVI – Risk Minimization Measures (RMMs) 📘 Purpose GVP Module XVI provides detailed guidance on the planning,...
Guideline on good pharmacovigilance practices: Module XV – Safety communication
✅ GVP Module XV – Safety Communication 📘 Purpose GVP Module XV provides guidance on how Marketing Authorization Holders (MAHs)...
Guideline on good pharmacovigilance practices: Module X – Additional monitoring
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional...
Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management
✅ GVP Module IX – Signal Management 📘 Purpose GVP Module IX provides comprehensive guidance for Marketing Authorisation Holders...
Guideline on good pharmacovigilance practices (GVP): Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies
✅ GVP Module VIII – Addendum I: Requirements and Recommendations for the Submission of Information on Non-Interventional...