November 16, 2018

Quality Requirements in GVP Module IX for Signal Management

Over the course of the last blog posts, the requirements of the four stages of the GVP Module IX Signal Management (GVP IX) process were discussed in great detail, along with specific ways in which Evidex Signal Management can help an organization to efficiently meet GVP IX requirements in a single, user-friendly, easy to implement platform built on a foundation of safety data and analytics.

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November 2, 2018

Signal Prioritization and Assessment in GVP Module IX for Signal Management

After an initial review, a determination is made whether the signal is non-validated or that it is in fact a validated signal that needs prioritization and further assessment.

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October 19, 2018

Signal Validation in GVP Module IX for Signal Management

Signal validation is the process of confirming a new potentially causal association, or a new aspect of a known association, of a drug-event combination. When validating a signal, GVP IX recommends that the following elements should be considered:

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October 5, 2018

The Signal Detection Process in GVP Module IX for Signal Management

Advera Health has long embraced the fact that safety signals can arise from a wide variety of data sources. The authors of GVP IX agree. The module specifies that common datasets include spontaneous reporting (MAH’s own database, national databases such as FDA Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase), active surveillance, studies, and scientific literature. All of these data sources should be considered depending on characteristics of the product and based on clinical judgement.

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September 21, 2018

An Introduction to GVP Module IX for Signal Management

Good Pharmacovigilance Practices (GVP) are a set of measures 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 processes. GVP Module IX - Signal Management (GVP IX) 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.

There are several aspects of the GVP IX process:

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September 7, 2018

A New Option for Safety Signal Management and Pharmacovigilance Workflow

Earlier this week we announced the release of Evidex Signal Management. Evidex Signal Management is a next generation pharmacovigilance workflow platform that allows an organization to track and resolve safety signals and inquiries. Built within Evidex’s best-in-class user interface, Evidex Signal Management provides audit ready tools that safety reviewers want to use. 
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