Acorn Regulatory September 2018 Newsletter

Hello and welcome to our September 2018 newsletter. We have had an interesting month. We have been shortlisted in three different awards and you can read more about that below.  In this edition of the newsletter we will  look at grouped variations, notified bodies and more.

As ever, we welcome your feedback to

Acorn Regulatory Shortlisted for 3 Awards!

We have been shortlisted for 3 awards!  We have been shortlisted in the ‘Pharma Supplier of the Year’ category at the Irish Pharma Awards, ‘Regulatory Support’ category at the TOPRA Awards and ‘Best Use of Social Media’ at the Co. Tipperary Business Awards.  Read more about the shortlists here.

Notified Bodies – The Implications for the Medical Devices Sector

The implications of Brexit will, possibly, be felt most in the area of Notified Bodies.  The UK’s exit from the European Union means that UK based Notified Bodies will no longer be permitted to provide conformity assessment services and issue CE Certificates of Conformity to manufacturers.  Read more here.

What Will A No Deal Brexit Look Like?  

The publication of a range of documents by the UK’s Department for Exiting the European Union (DExEU) finally outlines what the UK’s thinking is on a range of issues.  There has been much speculation and conjecture about how many sectors might be impacted by the UK leaving the European Union without a deal (a no deal Brexit) on March 29th 2019.  Read more about the possibilities here.

Subscribe To Our Brexit newsletter

Our limited series newsletter will look at the issue of Brexit from a regulatory perspective.  The newsletter series will run from September 2018 until the UK’s anticipated departure from the EU in March 2019.  Each edition will feature exclusive content, not available anywhere else, along with some of the best writing on the subject from our expert team and others.  Here, we are looking at what you can expect from the newsletter. Read more here.

What You Need To Know About MRP Grouped Variations

We have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations with clients. Here, we have outlined an overview on the topic. Read more about MRP Grouped Variations here.

#ICYMI – Featured Articles from the Acorn Regulatory Archive

Our #ICYMI series has looked at some of the best articles that have been written by members of the Acorn Regulatory team. They also present a good opportunity to bring to your attention articles that you might not have seen before and that might be useful to you.  This edition of the #ICYMI series looks at well established use, using a US dossier for an European application, how constant changes to legislation and directives can impose additional pressures on regulatory professionals and how new methods of conducting audits can help a company’s bottom line.  Dig deep into the Acorn Regulatory archives here.

‘Regulatory Intelligence 4’ Available To Download Now  

The latest edition of Acorn Regulatory’s Regulatory Intelligence is available to download now.  In this edition you can read some of the best writing on regulatory issues by our team of experts. Download it here now.

Join Our Team!

We are recruiting.  September has been a busy month for us and we have added a number of newly created roles to our website. Find out more about our current vacancies by clicking here.

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