Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDEileen RyanMarketing Authorisation HoldersPharmaceuticalSubmissions
How To In-Licence An eCTD Dossier
We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully. For instance, the eCTD...
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...
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...
The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
Did you know that Article 20 of Commission Regulation, known as the ‘Variations Regulation, allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one...
Acorn Regulatory April 2018 Newsletter
Hello and welcome to the April edition of the Acorn Regulatory newsletter. This month we are looking at Repeat Use Procedures, Clinical Breaches and we have another of our very well received ‘Regulatory Intelligence’ e-books. The e-book is filled...
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersPharmaceuticalRegulatory AffairsSubmissions
Repeat Use Procedure: What Are The Steps To Consider?
In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat Use Procedures. We explain what a Repeat Use Procedure is, the steps to take, and the pitfalls to avoid in...
Most Read Acorn Regulatory Pharmacovigilance Articles of 2017
It has been a very busy year for the Acorn Regulatory pharmacovigilance team. Over the course of the year we have worked with a large number of companies around the world. Our team has also produced a large number of...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceutical
Type I Variation: Apparently Not So Simple
In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a Type I variation. In this article, we look at the common validation issues, what to look for in relation to...
Product Information Text: Formats Suitable For Blind & Partially Sighted
Braille is an internationally recognised reading and writing system used by blind and partially sighted people. The braille alphabet consists of various arrangements of raised dots that make up each character. In accordance with European legislation, braille is required to...
NTK: Need To Know- 5 Pharmacovigilance Articles You Must Read
We produce hundreds of thought leadership pharmacovigilance articles on our site and in publications each year. Here are just 5 pharmacovigilance articles that you might have missed and that you should read.
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