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...

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

by Dr. Yashashwini Reddy | Jun 25, 2025

✅ GVP Module VIII – Addendum I: Requirements and Recommendations for the Submission of Information on Non-Interventional Post-Authorization Safety Studies (PASS) 📘 Purpose This Addendum supplements GVP Module VIII by providing detailed procedural and operational...

Guideline on good pharmacovigilance practices (GVP) – Module VIII – Post-authorisation safety studies

by Dr. Yashashwini Reddy | Jun 25, 2025

✅ GVP Module VIII – Post-Authorization Safety Studies (PASS) 📘 Purpose GVP Module VIII provides guidance on the design, conduct, and reporting of Post-Authorization Safety Studies (PASS) conducted by Marketing Authorization Holders (MAHs) after a product has been...

Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report

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...