#ICYMI – CE Marking, Non EU Dossier’s & More Articles From The Archive
In this first ICYMI (In Case You Missed It) of 2019, we look at four articles from the Acorn Regulatory archive. We look at CE Marking a medical device that contains a medicine, the difficulties associated with Type I variations,...
This Is What A No Deal Brexit Could Look Like For The Pharma & Devices Sector
Today’s publication (August 23rd 2018) 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...
10 of the Most Read Articles on Acorn Regulatory’s Website
Over the course of the year we have been highlighting some of the 100 most read articles on the Acorn Regulatory website. Again, we are featuring another 10 of the top 100 most read articles on this website. These articles...
#ICYMI – In Case You Missed It – Featured Articles from the Archive
Our expert team has written over 500 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this first edition of #ICYMI we are featuring articles...
The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
Did you know that Article 20 of Commission Regulation, known as the ‘Variations Regulation, allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersIndustry NewsMDRPharmaceuticalPharmacovigilance
How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceutical
Type I Variation: Apparently Not So Simple
In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a Type I variation. In this article, we look at the common validation issues, what to look for in relation to...
What The Newspapers Are Saying About The EMA Issue
The applications from potential host countries have been received and the ‘horse trading’ has begun. The decision on the EMA issue will be made by November. There is stiff competition from competing cities and many have made significant offers in...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Are You Prepared for a Pharmacovigilance Inspection?
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. In this article, we look at the measures that your company can take to be...
Industry News Roundup: October
In between constantly managing regulatory affairs submissions for our clients and dealing with some of the most dynamic healthcare companies around the world, our team has picked 5 of the top stories from the last thirty days.
