Brexit Case Studies: Are You Prepared?
The UK’s decision to leave the European Union will have a significant impact on life science companies in Europe. Companies need to start preparing now to ensure that disruption to their business is minimised once Brexit happens. We can help....
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Do You Know Your PV KPI’s? – Find Out More About Them Here
Our expert team has significant experience of working with clients to ensure that their pharmacovigilance systems are continuously improving. In this blog, we look at PV KPIs and the steps that your company can take. We consider issues such as...
Brexit Whitepaper No. 4 – What’s Next? – Download It Here
In our 4th Acorn Regulatory Brexit whitepaper entitled ‘What’s Next’ we focus on the results of our extensive Brexit survey. We look at our survey respondents favoured locations for the EMA, the future of the MHRA and much more.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Are You Prepared for a Pharmacovigilance Inspection?
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. In this article, we look at the measures that your company can take to be...
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceGemma RobinsonPharmaceuticalPharmacovigilance
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDGemma RobinsonHow-To & ExplainersPharmaceuticalSubmissions
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.
How Will The UK Life Sciences Sector Address Post Brexit Skills Shortages?
The UK pharmaceutical sector employs in excess of seventy thousand people. The structure of a Brexit will have significant impact on them and the industry that they work in. For now, there is a firm belief that the UK will...
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Advertising of Medicinal Products – An Overview
Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC). We look at the issues relating to advertising a...
