Can I read GVP Module IX: Signal Management Guidelines on EtoBox?
GVP Module IX: Signal Management Guidelines by Madhu Reddy is a document available to read on EtoBox.
What is GVP Module IX: Signal Management Guidelines about?
This document provides guidance on signal management practices in the EU. It outlines roles and responsibilities, monitoring procedures, and notification processes. It also describes signal detection, evaluation, prioritization and assessment by the Pharmacovigilance Risk Assessment Committee. The document seeks feedback on proposed criteria for access to case narratives and recommendations for monitoring frequency.
- Author
- Madhu Reddy
- Language
- EN