The Risk of No Deal Increases – ‘What Happens Next?’ – The 7th Acorn Regulatory Brexit Whitepaper

The seventh Acorn Regulatory Brexit whitepaper looks at the impact of a no deal departure from the EU on a number of sectors.

Brexit Whitepaper Acorn Reguylatory What Happens NextOur pharmacovigilance team look at the measures that companies need to put in place now if they are to prepare for the UK leaving the EU without a deal. The role of the QPPV has been much discussed in recent years, since the outcome of the referendum became known, and companies need to be aware of the implications that Brexit will have on that role.

The medical devices team look at the role of the EU Authorised Representative and the implications for Notified Bodies.  The devices sector is in a particular ‘state of flux’ at present with the introduction of new legislation and Brexit adds to the issues that device manufacturers need to be mindful of at this time.

Finally, our medical team look at the impact on clinical trials.  Trial sponsors and partners need to be aware of the impact of Brexit and the article contained in the whitepaper looks at what needs to be considered.

You can download the latest Acorn Regulatory Brexit whitepaper by completing the details below and we will send it straight to you.

We have also produced further Brexit publications, including:

Is Time Running Out? was published in 2018

Heading for the Exit was published in Q4 2016.

The Implications of Brexit was published in Q3 2016

As the thought leaders on the Brexit issue in the regulatory affairs sector we have also produced a number of articles relating to the UK’s decision to leave the EU.  You can read more HERE.

About the Authors

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

Dr. Danica Cvetkovic
Dr. Cvetkovic heads up our Clinical & Medical team at Acorn Regulatory. She has significant experience in the clinical and medical sector. Prior to joining our company she headed the medical department of a major pharmaceutical company in her native Serbia. You can read more articles by Dr. Cvetkovic by clicking the link below.
Other articles by Dr. Danica Cvetkovic

Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane

Natasha Daly
Pharmacovigilance Manager
Natasha joined Acorn Regulatory in October 2018 as Pharmacovigilance Manager. Natasha has over 11 years’ experience in the pharmaceutical industry. Her experience comes from working in a large global innovator pharmaceutical company and a large global generic company and includes drug development, post-marketing and clinical trials. Natasha`s role as pharmacovigilance manager at Acorn Regulatory is intended to ensure that the procedures in place are adhered to and that Acorn Regulatory provides a quality of service to its clients acceptable to any inspecting authority. You can read more articles by Natasha Daly clicking the link below.
Other articles by Natasha Daly

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