good pharmacovigilance practicesGood 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:

Signal Detection - The process of looking for and/or identifying signals using data from any source.

Signal Validation- The process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence to demonstrate the existence of a new potential causal association, or a new aspect of a known association, and therefore justifying further analysis of the signal.

Signal Prioritization- The process that identifies signals suggesting risks with a potential important patient or public health impact or which may significantly affect the risk-benefit balance of the medicinal product and thus require urgent attention and management without delay.

Signal Assessment and Recommendation for Action - The process of further evaluating a validated signal considering all available evidence to determine whether there are new risks causally associated with the active substance or medicinal product or whether known risks have changed. This review may include nonclinical and clinical data and should be as comprehensive as possible regarding the sources of information.

GVP IX specifically requires that a marketing authorization holder’s signal management system be adequately documented, and that the steps taken by the organization in the management of a specific signal be tracked (with recording of dates to confirm timeliness) and auditable. 

There is no specifications on how these requirements are met, but in the age of software-as-a-service (SaaS) and cloud-based technology, technology is playing an ever bigger role.

A series of blog posts will be released in the coming weeks that will summarize the process outlined by GVP IX and discuss how Evidex Signal Management can help organizations efficiently comply,
Don’t want to wait for all the posts? Download our Complete Guide to GVP Module IX for Signal Management or view our online guide here
Or learn more about Evidex Signal Management. 

Topics: Signal Management

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.