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Despite rapid advances in technology, pharmacovigilance (PV) teams while processing the adverse events (AE) still carries out majority of collaboration, communication and adhere to compliance through manual efforts. Once the AE data is captured, it is often stored in siloed systems making it difficult if not impossible to use it in meaningful ways.

According to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), the amount of adverse event reporting is increasing by more than 15 percent annually. Adding to this complexity, the number and variety of data sources PV units are expected to review is growing exponentially, making it increasingly difficult for PV professionals to keep up.

Cost-reduction pressures, dwindling safety talent and increasing requirements from regulators, are forcing the PV community to seek new solutions to improve the access, timeliness and cost-effectiveness of safety data management. As pharmaceutical companies step up their global PV transformation strategies, more effective PV processes are required, supported by robust technology, including cloud-based solutions, mobile applications, automation and artificial intelligence (AI), translating into smarter (but not necessarily higher) spend for PV activities.


Technology solutions are already a vital cog in PV operations in the pharmaceutical industry, given their strategic role in worldwide PV systems. While this notion of technology as an enabler to transformation carries across all areas of product development, it is evident that applying innovative technology automation tools and processes to PV is no longer an option but a must-have. Companies that recognize the importance of integrating newer, disruptive technologies and use these to fundamentally alter the drug safety continuum will see greater success in managing the safety of their products.


HALOPV can address the challenges in PV while enabling new levels of insight and proactive decision making to enhance quality and oversight for PV leadership. Many industries have already proven that AI and automation can deliver improved speed and quality in a variety of applications – the same benefits can be achieved for drug safety.

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