Acorn Regulatory NewsEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can Improvements Be Made To The Readability of Package Leaflets?
We look at the possible changes that could be made to package leaflets to improve their comprehension and readability.
Acorn Regulatory March 2018 Newsletter
In the March 2018 newsletter, we are giving you the chance to download our latest e-book and to read some of the most popular posts on our website in the last month. As always, we welcome any thoughts that you...
Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014
Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious breach of EU regulation No. 536/2014. The European Medicines Agency describes the regulation as: The goal of Clinical Trial Regulation EU No....
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Why More Companies Are Outsourcing Regulatory Affairs
The pharmaceutical and medical device sectors are facing unprecedented commercial pressures in every major healthcare market in the world. Issues such as increased competition, uncertainty regarding geopolitical issues such as Brexit and the individual nation’s drug pricing strategies have sent...
Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Is Well Established Use Going Out of Fashion?
The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make. One of the choices available, ‘well established use’ seems to waning in popularity as a choice amongst MAH’s. Here, we look...
Regulatory Intelligence 2 – Download It Here
Sector specialists need to stay on top of developments in the sector. That is why we have produced another edition of our e-book series. ‘Regulatory Intelligence 2’ looks at a number of the critical issues in today’s regulatory sector.
Four New Countries Join The EU – US Mutual Recognition Agreement for Manufacturing Sites
Four new entrants joined the EU-US Mutual Recognition Agreement for manufacturing sites for human medicines on March 1st. The four additional countries: Czech Republic, Romania, Greece and Hungary now join the eight existing members of the agreement.
Using a US Dossier for a European MA Application? Here Is What You Need To Know
Over the years, we have worked with a significant number of US innovator companies and supported them in getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the...
Preparing the Reference Safety Information for a Clinical Trial
What are the steps that companies need to take when preparing the reference safety information for a clinical trial? This article looks at the steps that you need to take.
