Safety Blogs

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

How far along are you in realizing benefits from automation? What is the biggest hindrance in adopting automation technologies? This two-part blog series analyzes polling responses from a recent DIA webinar and shares ArisGlobal’s thoughts on practical use cases for automation in pharmacovigilance and regulatory.

What is the greatest challenge across end-to-end pharma processes? How would you rate your automation capabilities? This two-part blog series analyzes attendee polling responses from a recent DIA webinar and shares ArisGlobal’s thinking about practical use cases for automation in pharmacovigilance and regulatory.

New EU regulation on data privacy, the General Protection Data Regulation, shines a Light on the benefits of automation to safeguard patient data when monitoring safety signals and ensuring pharmacovigilance databases can track changes to personal data and create an audit trail to remain GDPR compliant. Read the blog

Whether companies like it or not, consumers are discussing their products in social media forums. Comments about adverse events exist on patient forums, and on more generic social forums such as Facebook and Twitter. While much of what is said is not relevant or verifiable, there are safety signals that companies should be paying attention to, and that go to the heart of pharmacovigilance and social media.

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.

Pharmacovigilance is at a crossroads. The best, most innovative way forward for PV departments may well be automation, as they address the challenges (or market pull factors) and opportunities (or technology push capabilities).

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.

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.

On November 28, 2017, ArisGlobal held a webinar with DIA, “How Automation Can Deliver the Holy Grail in Safety: Achieve Productivity, Compliance and Quality”.  In this webinar, we posed a few questions to the audience, and came up with some interesting information.  We took this and spent some thinking about what this means to our clients in the PV ecosystem.