The March 2019 Acorn Regulatory Newsletter
We delayed our March 2019 newsletter because of…..you guessed it…Brexit. So, this slightly delayed newsletter contains three insightful and timely pieces about what to expect in a ‘no deal’ scenario. At the time of writing, April 1st, that is still the default position (unless the Withdrawal Agreement is ratified) and companies must prepare for that. The UK, indicative and meaningful votes notwithstanding, is due to leave the EU on April 12th.
What Will Happen To The QPPV Post Brexit?
As per DIR Art 104 (3) the Qualified person for pharmacovigilance (QPPV) shall reside and operate in the EU. Following EEA agreements, they may also reside and operate in Norway, Iceland or Liechtenstein.
But what will happen to the QPPV post-Brexit?
Read more here.
Will Clinical Trials Be Impacted By Brexit?
How will clinical trials be impacted by the UK’s decision to leave the European Union?
The United Kingdom’s decision to leave the European Union (EU) will present significant implications to the pharmaceutical industry. Clinical trial sponsors and associated partners should be prepared for a variety of scenarios arising from Brexit which could impact on the manufacturing, licensing and distribution of health products between Ireland and the UK.
Read more here.
Impact of Potential No-Deal Brexit Scenario on Medical Devices
The currently expected Brexit day of April 12th 2019 is fast approaching and with a no-deal or cliff edge Brexit a very real possibility, there are several key areas for medical device companies to consider in terms of impact to their business in the event of a no-deal Brexit scenario. We wish to highlight here two areas for consideration for the medical devices sector.
Read more here.
Have You Seen Our Latest Vacancies?
We are a growing regulatory affairs consultancy company. Right now, we are recruiting for experienced individuals in a number of our teams. Check out of latest vacancies here.
Acorn Regulatory To Speak at RQA Ireland Forum 2019
We will be speaking at the 2019 RQA Ireland Regional Forum on May 23rd at The Kingswood Hotel in Dublin. The 2019 event will focus on the theme of ‘Chain Reactions & Interactions’ and will look at the uncertainty that dominates the life sciences sector at the moment. You can see the agenda and book your ticket to attend here.
#ICYMI
This edition of #ICYMI could easily be called the ‘What?’ edition. We look at 4 articles from our archive that ask and answer important questions in regulatory affairs, quality and careers.
Read more here.
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