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...
How To Complete A Type I Variation
Type I Variations to a Marketing Authorisation are surprisingly difficult. The procedure that many people perceive to be a simple process can prove to be otherwise. This article looks at how to complete a type 1 variation and we will...
What Regulatory Affairs Training Courses Are Available in Ireland?
Perhaps one of the most frequently asked questions that our team members get is “how do you get started in regulatory affairs?” Every single person on our team has taken a different path over the course of their careers to...
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover...
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 NewsAcorn Regulatory's Top 100 ArticlesEU Authorised RepresentativeIVD DevicesMDD DevicesMDRMedical Devices
Understanding MDR: 8 Important Changes
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations will bring about many changes compared to the current regulatory framework. We look...
What’s Happening with the eSubmission Roadmap?
The eSubmission roadmap is filled with significant dates that can impact on your business. Here, we look at developments on the eSubmissions roadmap up to 2020.
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmacovigilance
How Can Remote Audits Reduce Your Pharmacovigilance Costs?
Can remote audits really reduce costs for PV departments? The remote or desktop audit is growing in popularity as client companies assess costs and the environmental impact of traveling to an audit site. Furthermore, the restrictions on movement and travel...
Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know
What is virtual wholesaling? It is a topic that we get asked about time and again. So, we have produced a quick to read guide detailing 5 things that you need to know about the topic.
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