Using state-of-the-art technology to combat challenges unique to 21st century culture

Using state-of-the-art technology to combat challenges unique to 21st century culture

Since I now have a piqued interest in the application of artificial intelligence in pharmacovigilance, I was interested to read the findings from a study using machine learning to identify ICSRs in social media.  Until now, my impression of ADRs reported in the social media was that identifying valid ICSRs was more than challenging due to their diversity, complexity, colloquialisms and anonymity. Also, it seems the regulatory authorities acknowledge these challenges as it is not yet a regulatory requirement to monitor social media as a source for ICSRs. But is this looking set to change if machine learning and automation become the norm? Continue reading “Using state-of-the-art technology to combat challenges unique to 21st century culture”

E2B R3: the countdown is over

E2B R3: the countdown is over

After many years of planning, on 22nd November 2017 the EMA’s EudraVigilance system started accepting ICSRs submissions in the E2B R3 format. This was one amongst many changes made to EudraVigilance on this date, but implementation of R3 is certainly one of the most significant milestones. The switch from R2 to R3 is not simply a technical format change, but has potential upstream and downstream effects on case processing and other PV activities. Although there will be expected challenges in transitioning to a new ICSR format, there may also be unexpected benefits. Continue reading “E2B R3: the countdown is over”