Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can You Use A U.S. Dossier To Apply For A European Marketing Authorisation?
Is it possible to use a U.S. dossier when applying for an E.U. marketing authorisation? This is a question that is asked time and again. We first published this article in 2017. We have updated it and included links to...
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...
In Case You Missed It from Acorn Regulatory: CEP’s, Orphan Drugs, Packaging & More
Our expert team has written hundreds of insightful articles on all aspects of regulatory affairs, pharmacovigilance, clinical trials, compliance and more. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this latest edition...
Your eCTD Questions Answered
Acorn Regulatory’s publishing team is staffed by eCTD experts. We have assisted many companies in their eCTD projects in recent years. Many visitors to our website submit questions on regulatory issues. In this blog post, Eileen Ryan, our Regulatory Publishing...
Acorn Regulatory April 2019 Newsletter
In the April 2019 newsletter we look at one of the most popular articles in recent years on our website. We have updated ‘What Are The Initial Steps in Applying for a Marketing Authorisation?’ to reflect changes in legislation. In...
In Case You Missed It – Articles from the Archive -#ICYMI
Welcome to this month’s edition of ICYMI from Acorn Regulatory – looking at articles from the Acorn Regulatory archive that you might have missed when they were first published.
#ICYMI – Articles From The Acorn Regulatory Archives
This edition of #ICYMI from the Acorn Regulatory archives could easily be called the ‘What?’ edition. We look at 4 articles from our archive that ask and answer important questions in regulatory affairs, quality and careers.
The February 2019 Acorn Regulatory Newsletter
Welcome to the first newsletter of Spring! In the February 2019 newsletter we are looking at the issue of scientific literature,the common variation validation issues, looking back at some of the most read articles on our site and much more. ...
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonMarketing Authorisation HoldersPharmacovigilance
Pharmacovigilance & Social Media in 2019
In 2015 we looked at the emerging role of social media in pharmacovigilance. Revisiting the topic over 3 years later we are glad to say that the field has moved on substantially in terms of research into the practical applications...
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