Clinical Trials in Ireland: Is Ireland The Place To Be?
Significant 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...
The eCTD Deadline is Looming: Are You Ready?
For those of us working in the regulatory affairs sector, there is always a deadline to contend with. We deal comfortably with client deadlines every day. However, the new deadlines that are causing the most unease in the life sciences sector are...
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Pharmaceutical Code of Practice – Are You Aware of Your Responsibilities?
Acorn Regulatory assists companies in maintaining compliance with a variety of codes of conduct. In this article, we look at the issues surrounding the code of practice that governs pharmaceutical companies in the UK and Ireland. The respective IPHA and...
The Future of the European Medicines Agency
It could be argued that the European Medicines Agency is a bell weather for the plight of the Brexit negotiations. The Canary Wharf based agency is at the centre of much wooing from EU member states while the UK...
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How Do You Translate Your Non-EU Dossier For The EU Market?
The issues faced when translating a non-EU dossier for the EU market is covered in this blog by the CMC team at Acorn Regulatory.
Do Patient Groups Have A Role In Package Leaflet Creation?
What role do target patient groups have in the creation of a package leaflet? We look at the issue and the directives concerning package leaflets in our blog.
EU Authorised Representatives Post Brexit: What Happens Next?
The UK’s impending departure from the EU will necessitate a change in designated EU Authorised Representatives for companies that are currently using a UK based authorised representative at present. This will cause considerable upheaval and disruption to companies using such...
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A New Approach to The Pharmaceutical Quality System
Is your quality system keeping pace with the changes in manufacturing technology and new thinking in how manufacturing companies approach the issues of quality? Many companies have adopted the pharmaceutical quality system outlined in ICH Q10 and experienced the benefits...
STEM Careers in South East Ireland
In the latest Acorn Regulatory careers blog our CMO Brian Cleary writes and speaks about the importance of STEM careers to the south east of Ireland and the launch of the new South East Regional Skills Forum.
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 to the 2007 guideline earlier this week (November 15th).
