EMA Guidelines on First in Human Trials Revised
The EMA guidelines on first in human clinical trials have been revised. The European Medicines Agency issued its proposed revisions to the 2007 guideline earlier this week (November 15th).
Brexit & Regulatory Affairs – The UK Is Heading for the Exit
In an extract from our second Brexit whitepaper, we look at the impact of Brexit on regulatory affairs and issues such as the future of the European Medicines Agency, Pharmacovigilance and Brexit and much more.
How Will The UK Life Sciences Sector Address Post Brexit Skills Shortages?
The UK pharmaceutical sector employs in excess of seventy thousand people. The structure of a Brexit will have significant impact on them and the industry that they work in. For now, there is a firm belief that the UK will...
Industry News Roundup: November
This month in our news roundup we are looking at Wholesale Distribution Authorisation (WDA), President-Elect Trump, awards and more.
Who Will Host The European Medicines Agency?
For those of us working in the sector, the future location of the European Medicines Agency has been a consistent topic of conversation since the outcome of the Brexit vote became known.
Download Our Latest Brexit Whitepaper – Heading for the Exit
Where Next for the European Medicines Agency? In our second Brexit whitepaper, we are looking at the implications of the decision to leave on one of the most ‘mission-critical’ agencies of the EU – the European Medicines Agency. The future...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesAdvertisingComplianceGemma RobinsonPharmaceutical
Advertising of Medicinal Products – An Overview
Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC). We look at the issues relating to advertising a...
Acorn Regulatory Managing Director Shortlisted for Business Award
Dr Gemma Robinson, Acorn Regulatory Managing Director, has been shortlisted for the Digital, Science & Technology Businesswoman of the Year award in the Image Awards.
CE Marking a Medical Device That Incorporates a Medicine
We are consistently asked about CE marking a medical device. Our team of medical device experts has written a brief overview of how a company can secure CE marking for a medical device that incorporates a medicine.
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.
