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”
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.
Report from the DIA Pharmacovigilance and Risk Management Strategies Conference, January 23-25, 2017, Washington, DC.
Written by Suzanne Berresford, Product Manager, Pharmacovigilance, Springer Nature
The nature of medicinal products is in a rapidly shifting world, with therapeutic innovation becoming a major global trend that is here to stay. The precision medicine approach and use of targeted therapies such as biologicals, gene therapy and stem cell therapy is weaving its way into standard practice but questions still remain about monitoring the long-term safety and efficacy of such advanced therapies. The DIA Pharmacovigilance and Risk Management Strategies Conference set out to discuss some of the challenges and to provide an opportunity for pharmacovigilance professionals to share their experiences in these areas. Continue reading “A brave new world: what does the future hold for pharmacovigilance?”