Brexit: The Implications on Existing Marketing Authorisations
In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations.
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...
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Periodic Safety Update Single Assessment Updates
In December 2015, we published a pharmacovigilance article “Periodic Safety Update Single Assessment (PSUSA) – An Overview” which outlined the process the European Medicines Agency(EMA) take to monitor the safety of medicines in Europe. Periodic safety update reports (PSURs) are pharmacovigilance documents submitted...
Medical Literature Monitoring (MLM) – Current Status
The 1st September 2015 saw the rollout of the European Medicines Agency’s (EMA’s) much anticipated medical literature monitoring (MLM) service. The service was launched in summer 2015, focusing on the top 50 active chemical substance groups. Since last September, the...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Periodic Safety Update Single Assessment (PSUSA) – An Overview
In this blog, we look at the Periodic Safety Update Single Assessment or PSUSA.
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Update on the new EU In Vitro Diagnostic Medical Device Regulation: Seven Key Changes
Editor’s note: This post was first published in November 2015. Since then we have written extensively on the issue of medical devices and the MDR/IVDR. You can read more about devices here. You will see that some of our comprehensive...
TOPRA Symposium Blog: What Does The Industry Think of Brexit?
After more than 3 years of formal negotiations, political turmoil and an ‘aerial warfare’ on multiple media platforms, the UK plans to leave the EU at the end of this month. However, it might not actually be leaving if an...
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Updated: How To Prepare 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. We look at the measures that your company can take to be prepared.
Acorn Regulatory NewsBrexitEU Authorised RepresentativeMarketing Authorisation HoldersMedical Devices
No Deal Brexit Planning – What We Know So Far
The ongoing coverage of the UK’s moves towards leaving the European Union continues. This is a difficult time for companies in the life science sector in the UK and outside of the UK as they work to ensure that patients...
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersRegulatory Strategy
What MAH’s Need to Know About Outsourcing
The continued growth of outsourcing of manufacturing in the pharmaceutical industry and the use of more complicated supply chains means that in certain situations the Marketing Authorisation Holder (MAH) can become very far removed from manufacturing process and products. However,...
