Recent advancements in technology are enabling automation to help address the growing PV challenges organizations face. Yet, when webinar attendees were asked “Does your company have a strategic plan for PV Automation?” responses were mixed.

This is the second in a three-part blog series on National Pharmacovigilance systems and the role of technology in bridging the gaps in pharmacovigilance of regulatory authorities around the world.

One of the key roles of pharmacovigilance departments is to understand the benefit-risk profile of a drug. But departments are often bogged down by manual tasks that can absorb time, which might be better spent on value-centric activities. Perhaps the most tedious pharmacovigilance activity is medical literature monitoring (MLM), and as we discussed in our last blog, manual, repetitive tasks are a primary cause of employee dissatisfaction.

On June 5th, 2019, ArisGlobal held a webinar focused on the “Key Use Cases of Automation in Pharmacovigilance.” During that event, 84% of attendees indicated a significant increase in their case volumes over the last five years. Only 15% considered their case volume increases to be ‘slight.’

There has been significant changes in the way the EMA expects MAHs to handle ICSRs from the new EudraVigilance system, creating additional work for already busy pharmacovigilance departments