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...
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...
