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...
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.
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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...
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.
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Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
The Implications of Brexit for the Life Sciences Sector
The implications of Brexit are still being felt. Politically, the decision has triggered a chain of events that none of us could have ever foreseen. Now, with a new Prime Minister in Downing Street and three leading ‘Brexiteers’ appointed to offices...
EMA Introduces New Chapter on Good Pharmacovigilance Practices (EU-GVP)
The European Medicines Agency has added a new chapter (Product- or population-specific considerations II: Biological medicinal products) to its guidelines on good pharmacovigilance practices – EU GVP. The new GVP guidance comes into force on August 16th 2016. The new chapter...
Brexit Clinical Trials Sector Implications
In this extract from our first Brexit whitepaper we look at the implications of Brexit for the clinical trials sector.
The Implications of Brexit on the Pharmaceutical, Medical Devices & Clinical Trials Sectors
Acorn Regulatory has published a whitepaper looking at the potential implications of Brexit on a number of healthcare sectors. The document looks at the impact of the UK’s decision to leave the EU on institutions such as the EMA. It also...
