Acorn Regulatory NewsIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application
What is KASA and how will it impact on getting a drug assessed by the US FDA? We look at its ‘3 pillars’ and what it aims to be. Importantly, we look at how the FDA believes it will change...
Brexit Pharma Info: Updated for 2019
The election of Boris Johnson as the new Prime Minister of the United Kingdom has put the issue of Brexit firmly back on the political agenda, after a number of months of relative inactivity. His stated willingness to pursue a...
What Will Happen To The QPPV After Brexit?
Brexit will impact on many aspects of the life sciences sector. One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV). In this article, we consider the impact that...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory Affairs
UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?
We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA). In this article we aim to provide a guide to assist companies applying for an MA We have also provided a number of links throughout...
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory Affairs
What Are The Common Variation Validation Issues? Find Out Here
Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations...
Brexit: What’s Happening?
The decision, on January 29th, by the UK Parliament to seek to re-open negotiations with the European Union, leaves companies in a state of limbo. Companies, and individuals, do not have a definitive Brexit roadmap. Nevertheless, companies need to prepare...
2018’s Most Read Publications from Acorn Regulatory
Over the course of the past year we have produced a wide range of whitepapers, ebooks and other publications. Here are the 5 most read publications from Acorn Regulatory in 2018
2018’s Most Read Brexit Articles from Acorn Regulatory
Brexit negotiations and machinations have dominated the news headlines for the past 12 months. The strong negotiating stance of the EU has been contrasted by the difficulties besetting the UK government as they sought to find a form of Brexit...
Acorn Regulatory August 2018 Newsletter
Hello and welcome to our August 2018 newsletter. This month we are featuring a new e-book from our ‘Regulatory Intelligence’ series. We also look at a number of Brexit related issues. Don’t forget that you can subscribe to our new limited...
Blog: Brexit Pharma Update – The EMA Survey
The results of The European Medicines Agency Brexit preparedness survey, released in July 2018, show that the majority of Marketing Authorisation Holders (MAH’s) are taking steps to make the necessary changes to their marketing authorisations.
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