Be a pharmacovigilance superhero

In recent years, pharmaceutical companies and government bodies have placed increasing emphasis on safety and pharmacovigilance risk management. This is largely driven by a number of high profile drug withdrawals in addition to growing consumer expectation regarding drug safety. Compounding these pressures to pharmacovigilance is the deluge of adverse event information from sources ranging from social media sites, published literature, conferences, pre-clinical and clinical trials, patient healthcare reports, etc. Given the high cost of failure, companies remain focused on comprehensive tracking of drug adverse events, while being cautious of false information.

Pharmacovigilance also requires the tracking and reporting of drug safety issues from multiple geographies to multiple regulatory agencies, which all involve different procedures and require different types of information. For example, in the European Union, there are different rules in different member countries for labeling standards and reports. Reports need to be made to individual member countries, duplicating effort for pharmacovigilance teams and Information managers that are already under pressure. The consequence is that pharmacovigilance groups must maintain a repository of adverse drug reactions (ADR) data, while also keeping up with changing global regulatory safety requirements.

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