Brexit Whitepaper No. 4 – What’s Next? – Download It Here


In our 4th Acorn Regulatory Brexit whitepaper entitled ‘What’s Next’ we focus on the results of our extensive Brexit survey.  We look at our survey respondents favoured locations for the EMA, the future of the MHRA and much more.

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:

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  • combination products regulated as medical devices

The brief whitepaper also provides a handy drug-device checklist.

Download it here.

Download ‘Regulatory Intelligence 8’

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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:

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You can download your copy here.

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Download the whitepaper here.

Get The Latest eCTD Publishing Whitepaper Now

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Read the eCTD book here.

The Risk of No Deal – The Seventh Whitepaper

As the risk of no deal increases, we examine how this will impact on the role of the QPPV, the EU Authorised Representative and the clinical trials sector in the UK.  Download your copy of the 7th Brexit whitepaper here.

About the Author

Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD

Brian Cleary
Chief Marketing Officer
Brian is Chief Marketing Officer at Acorn Regulatory. He works with our growing team to highlight some of the most important issues in regulatory affairs and pharmacovigilance. Brian also manages HR and recruitment issues for the company. You can read other articles by Brian by clicking the link below.
Other Articles by Brian Cleary