Clinical Trials

Guidelines For Notification of Serious Breaches of Regulation (EU) No. 5362014

Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014

Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious […]

Preparing the Reference Safety Information for a Clinical Trial

Preparing the Reference Safety Information for a Clinical Trial

In this article, we look at the steps that companies need to take when preparing the reference safety information for […]

Clinical Trials and Brexit

Blog: Clinical Trials and Brexit

In this blog, Brian Cleary looks at clinical trials and Brexit.  He also looks at the issues surrounding the UK’s […]

Clinical Trials in Ireland: Is Ireland The Place To Be?

Great progress has been made in recent years in Ireland to advance the capability in design, conduct, analysis and reporting […]

regulatory affairs e-book from Acorn Regulatory

Download ‘Regulatory Intelligence’ – Our Latest E-Book

Our team of regulatory affairs experts are regarded as the thought leaders in the sector.  They have worked on some […]

EMA Guidelines on First In Human Trials

EMA Guidelines on First in Human Trials Revised

The EMA guidelines on first in human clinical trials have been revised.  The European Medicines Agency issued its proposed revisions […]

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A Tightening of Regulations for Phase I Clinical Studies?

The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase […]

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FDA Seeks Input on New Technology for Conducting Clinical Trials

Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting […]

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