Acorn Regulatory NewsBrexitIndustry NewsJanet FitzgeraldMarketing Authorisation HoldersPharmaceutical
Watch The Northern Ireland Protocol Webinar
Acorn Regulatory hosted a webinar in association with TOPRA on March 4th, 2021 to look at the issue of the Northern Ireland Protocol from a consultancy standpoint. The webinar was a fully booked event and generated significant interest among regulatory...
Expectations for Human Use Products During The Covid-19 Pandemic
The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency have developed a ‘questions and answers’ document in light of the ongoing Covid-19 pandemic. The aim of the document is...
Acorn Regulatory NewsBrexitChristine McGrathClinical & MedicalDanica CvetkovicGemma RobinsonMarie CarrollMarketing Authorisation HoldersPharmacovigilancePublicationsRegulatory Strategy
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‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitMarketing Authorisation HoldersPharmaceuticalPharmacovigilance
EU Based QPPV – Is Your Company Ready for Brexit?
As Brexit negotiations reach their most critical point, it looks today (October 17th, 2019) that a deal is in sight. The EU and the UK have agreed a deal and the UK Parliament are now set to vote on the...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDEileen RyanMarketing Authorisation HoldersPharmaceuticalSubmissions
How To In-Licence An eCTD Dossier
We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully. For instance, the eCTD...
Acorn Regulatory NewsIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application
What is KASA and how will it impact on getting a drug assessed by the US FDA? We look at its ‘3 pillars’ and what it aims to be. Importantly, we look at how the FDA believes it will change...
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,...
Brexit Pharma Info: Updated for 2019
The election of Boris Johnson as the new Prime Minister of the United Kingdom has put the issue of Brexit firmly back on the political agenda, after a number of months of relative inactivity. His stated willingness to pursue a...
What Will Happen To The QPPV After Brexit?
Brexit will impact on many aspects of the life sciences sector. One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV). In this article, we consider the impact that...
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