Preparing for a No Deal Brexit – The 9th Acorn Regulatory Whitepaper
The seemingly never-ending Brexit negotiations have continued throughout the pandemic. Talks initially held virtually, have now progressed to face to face meetings. While the format of the meetings might have changed there has been little progress to report as both sides struggle to reach a deal that can be voted on by the European and UK parliaments. It looks like we are headed for a no-deal Brexit and companies need to be preparing for a no deal Brexit.
In the event of no-deal being agreed by the negotiating parties, there will be a significant change to how business is carried out between the European Union and the United Kingdom. The UK has opted not to seek an extension to the transition period that expires at the end of 2020. The potential break will have a significant impact on many aspects of the life sciences sector, many of which are outlined in this whitepaper.
This whitepaper looks at the impact that the break between the UK and the EU will have on the pharmacovigilance sector in the form of the PSMF and the role of the EU QPPV. We also look at the issue of clinical trials and Brexit. The UK is a world leader in the sector.
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You can download the latest Brexit whitepaper in the series, the ninth, by completing your details below and we will email the whitepaper to you directly. While you are completing the form we would really appreciate it if you could subscribe to our newsletter by ticking yes to receiving communications from Acorn Regulatory.
Further Reading from Acorn Regulatory
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.