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...

Guideline on good pharmacovigilance practices (GVP) – Module VI Addendum I – Duplicate management of suspected adverse reaction reports

by Dr. Yashashwini Reddy | Jun 25, 2025

✅ GVP Module VI – Addendum I: Duplicate Management of Suspected Adverse Reaction Reports 🔹 Purpose This Addendum to GVP Module VI provides guidance on how Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs) should manage duplicate...

Guideline on good pharmacovigilance practices (GVP) – Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products

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...