Join us for a live webinar at the end of March to discuss “The new E2B R3 – Challenges and considerations.” Continue reading “Webinar on the new E2B R3 – Challenges and considerations”
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”
Automation, machine learning, artificial intelligence, robots – hearing such terms mentioned in the workplace can strike fear in the everyday employee, that soon the human workforce will be replaced entirely by a ‘digital workforce’. And of course many sci-fi movies only play on this hype. Whilst in certain industries or for specific job roles there may be more than an element of truth to this, in the pharmacovigilance world, using machines to supplement human input is not only a necessity but also a blessing. Or so I learnt at the International Society of Pharmacovigilance (ISOP) Seminar on Intelligent Automation in Pharmacovigilance, held in Boston in December 2017. Continue reading “Why rise of the machines will be beneficial in the pharmacovigilance world”
Report from the DIA’s Pharmacovigilance and Risk Management Strategies Conference, Washington, DC, 22-24 January 2018
Despite the US government shutdown resulting in a noticeable absence of FDA personnel, the DIA’s Pharmacovigilance and Risk Management Strategies conference was a well-attended event. The conference was hosted in Washington, DC, from 22-24th January 2018. As usual the programme was excellent, extensive and covered many hot topics; a recurring theme was how quickly some players in the PV industry are adapting to modern-day challenges including newer technologies for treatment, so-called big data, seemingly incessant social media and the rise of artificial intelligence. Continue reading “The Year of the Dog: If you can’t run with the big dogs, stay on the porch”
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”
“The first thing you feel when a trial fails is a sense of shame,” says physician Siddhartha Mukherjee. Then comes the “exhilarating — and dangerous” instinct to slice and dice the data to resurrect the drug’s potential.
Here Siddartha discusses the lure to make more of the science than is perhaps there, when stakes are high and we are desperate to find hope for patients who are out of treatment options. Continue reading “When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results”
Report: Pharmacovigilance Strategy Meeting, Boston, MA, USA November 2017
In less time than it took for me to travel to the meeting from New Zealand – the day was over! Hard to believe that within a short eight hours, 25 lively roundtables were conducted, two keynote speeches were delivered, and the panel discussed the learning of the day, including challenges of monitoring diverse sources, importance of real-world evidence in the context of risk benefit, and the game-changing impact of artificial intelligence. Continue reading “1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?”
Join me for a live webinar and Q&A session in June, when we will find out how organisations are managing integration with EMA’s Medical Literature Monitoring (EMA MLM) service and gaining a better understanding of the limitations.
Our partners Amplion recently published an interesting blog post on the benefits of biomarkers in informing earlier decisions in the drug development process – “fail early, fail fast” to save time and money, and increase approval success. An interesting read, check it out! Continue reading “Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers”
The second in a two-part series of live webinars on Pharmacovigilance and Safety Biomarkers is set to take place on Tuesday, March 21, 2017.
Joining forces with Amplion, the leading biomarker business intelligence company, we aim to provide useful insights for anyone involved in R&D, product strategy decisions, or working directly in a drug safety related role.
During the webinar, our speakers will cover: Continue reading “Date announced for next safety biomarkers webinar”