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...
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...
