We have spent almost a year pondering the next steps and now, here we are at a point where Article 50 has been triggered and the negotiations for the UK to depart the EU are about to begin. In recent months, I, along with my colleagues, have been travelling around Europe and meeting with senior management and regulatory teams to look at the potential implications of Brexit on their businesses. We have listened to the concerns of many like-minded industry professionals about the possible impact of Brexit on their businesses.
In this edition of the Acorn Regulatory Brexit whitepaper we publish the results of our exclusive survey of almost 250 regulatory affairs professionals. We highlight their thoughts on the future of the EMA, the location of the agency, the challenges facing their companies and much more. We would like to take this opportunity to thank everybody who took the time to complete the survey. If you did not get a chance to complete this survey but would like to share your thoughts on the issue then please get in touch.
If you would like to read the Acorn Regulatory Brexit whitepaper ‘What’s Next’ and find out which European city is regarded by our survey respondents as the most likely to host the EMA then simply complete your details below and you will receive a copy of it straight to your inbox.
Below the webform you can read more Brexit related articles from the team at Acorn Regulatory.
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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?
