Brexit: One Year On – The 5th Acorn Regulatory Whitepaper
Brexit: One Year On is the 5th Acorn Regulatory whitepaper. In this edition we look at some of the most pressing issues for regulatory specialists such as the changes to marketing authorisations, the need to move EU Authorised Representatives and more.One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies are setting plans in place to deal with a new regulatory landscape.
In the past year we have published a number of very well received whitepapers and thought leadership articles on the issue of Brexit. Our work has been acknowledged by major media organisations such as Politico and a wide range of niche publications and websites. Now that the negotiations have begun, we think that it is an appropriate time to revisit a handful of the most widely read and quoted pieces from the last twelve months. We are regarded as the industry leaders on the subject and, consequently, we are working with a large number of pharmaceutical and medical device companies on their Brexit related issues. The pieces contained herein look at issues such as marketing authorisations, EU authorised representatives and more.
Download the whitepaper today to find out more about the issues surrounding marketing authorisations and Brexit, the need to consider a new EU Authorised Representative and more.
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The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.
The drug-device whitepaper looks at issues such as:
- the regulatory framework for devices
- what is a drug-device product and how are they defined as such?
- how are they regulated
- how does MDR change the requirements for drug-device products?
- combination products regulated as medical devices
The brief whitepaper also provides a handy drug-device checklist.
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including pharmacovigilance, CMC & pharmaceutical, and medical device.
‘Regulatory Intelligence 7’ is now available to download. It is the latest edition in our popular series ‘Regulatory Intelligence’.
This edition covers the following issues:
- Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
- Clinical Investigations Under MDR
- The U.K. PSMF -What Will It Look Like?
The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR.
Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing. Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download.