The RxView Blog

We've heard a lot about the 'new normal' lately.  The world we knew at the beginning of 2020 is very different from the world that we are now cautiously reopening. Here in Massachusetts, the final phase of reopening is even called "The New Normal".

Everyone I speak to has an opinion on how we should deal with this new normal.

I have trouble just dealing with it: 

We work with biopharma companies across the size spectrum.  When small and medium sized companies with marketed products first approach us, many of them have not implemented a software solution for signal management.  Why?  Many feel their case volumes are not high enough. Others believe they don’t have the right in-house resources. Still others have “a great spreadsheet that works just fine”. All of these excuses, err, reasons boil down to one thing: FEAR.

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.

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.

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:

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.

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: