Chapter 1: Introduction to GVP Module IX for Signal Management
Chapter 2: The Signal Detection Process
Chapter 3: Signal Validation
Chapter 4: Signal Prioritization and Assessment
Chapter 5: Quality Requirements
Good Pharmacovigilance Practices (GVP) are a set of measures drawn up, and put into practice in 2012, to facilitate the performance of pharmacovigilance in the European Union (EU). GVP is broken out into several modules that govern different aspects of pharmacovigilance process. GVP Module IX - Signal Management (GVP IX) was adopted and put into effect in 2012 and provides general guidance and requirements on scientific and quality aspects of signal management.
The guidelines apply to Marketing Authorization Holders (MAH) for medicines authorized by the European Medicines Agency (EMA) and EU Member States. However, in the absence of formal regulation on the process of signal management by other health authorities, such as FDA, these guidelines have become the de facto global standard.
This guide is intended to provide a comprehensive overview of GVP IX and discuss how Evidex Signal Management, a next generation pharmacovigilance workflow platform can help organizations detect, track, and resolve safety signal and inquiries in compliance with GVP IX.
A next generation pharmacovigilance workflow platform that allows an organization to track and resolve safety signals and inquiries.
Built within the Evidex framework, Evidex Signal Management provides audit ready tools that safety reviewers want to use
Fully integrated and automated signal detection from multiple data sources, powered by Evidex Data & Analytics provides a wholistic, modern approach to pharmacovigilance
Validated off-the-shelf configuration based on GVP Module IX offers fast, compliant, and lean implementation, while maintaining the flexibility to meet any organization's unique needs
