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.
To receive the free whitepaper simply complete your details below and we will email it to you straight away. Also, don’t forget to subscribe to our monthly newsletter to stay right up to date with all of the regulatory related developments in the Brexit process.
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Drug-Device Whitepaper
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
Download ‘Regulatory Intelligence 8’
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. Download it here.Download ‘Regulatory Intelligence 7’ from Acorn Regulatory
‘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?
