Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious breach of EU regulation No. 536/2014. The European Medicines Agency describes the regulation as: The goal of Clinical Trial Regulation EU No. 536/2014 is to create an environment that is favourable to conducting clinical trials in the EU, with the […]
In this article, Vanessa Hyde looks at the steps that companies need to take when preparing the reference safety information for a clinical trial.
In this blog, Brian Cleary looks at clinical trials and Brexit. He also looks at the issues surrounding the UK’s departure from the European Union.
Great progress has been made in recent years in Ireland to advance the capability in design, conduct, analysis and reporting of clinical trials. Patients, researchers, academics, clinicians and industry along with the Health Research Board have worked tirelessly to develop this framework. Yet, with all of these developments, Ireland still only participates in less than […]
Our team of regulatory affairs experts are regarded as the thought leaders in the sector. They have worked on some of the most challenging and ground breaking regulatory projects in modern times. They regularly write for specialist periodicals and speak at industry events. In this, the first edition of ‘Regulatory Intelligence’ we have asked them […]