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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August 10, 2018

Are Social Media Data used in Pharmacovigilance Biased?

In addition to asking questions around the value and validity of using social media monitoring for pharmacovigilance, we also often get questions around our thoughts on whether social media data are inherently biased. When I brought this question to the Booz Allen Epidemico data team, they educated me on the three dimensions of bias that come from different drug safety datasets: Patient reported outcomes, seriousness, and completeness. The graphic below shows how those three dimensions differ across social media, clinical trials, spontaneous reports, and EHR records.

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July 27, 2018

Reducing the Noise from Social Media for Pharmacovigilance

One of the biggest fears that pharmacovigilance professionals have when it comes to using social media is that amount of work that it will create. How will you be able to take the time needed to "clean" the data and get it fit for analysis? Machines can be trained to identify posts with drug-adverse event combinations, but it is more difficult for them to be able to ensure the post is an accurate representation of an adverse event. Thus, Booz Allen's Epidemico team uses human curation to provide the most accurate data.

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July 13, 2018

What's Driving Pharmacovigilance Technology Acquisition?

In recent years, the rapid development of “big data analytics” has created a surge within pharmaceutical companies to leverage data from the entire value chain to drive actionable insights. Although other departments within pharmaceutical companies have long been focused on utilizing data driven insights, modern pharmacovigilance departments are just starting to fully incorporate a data-and-analytics-first approach to signal detection, validation, and management.

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June 29, 2018

The Value and Validity of Social Media Monitoring in Pharmacovigilance

In talking with current and prospective clients around Advera Health's partnership with Booz Allen's Epidemico social media monitoring data, we get asked a lot about not only the validity of the process Booz Allen goes through to cut through the "noise", but also about the value social media monitoring has for post-marketing drug safety surveillance and pharmacovigilance. In addition to highlighting the primer we put together, we also refer those interested to the numerous academic publications on the topic. Three core publications that Booz Allen has conducted in collaboration with regulators and industry serve as a starting point, and below is a summary of key points and links to the full publications. 

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