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...
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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...
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover...
‘RQA Ireland Conference – Chain Reactions & Interactions – Review
Acorn Regulatory was the main sponsor for the 2019 RQA Ireland Conference held at the Kingswood Hotel, Citywest on May 23rd. The event, entitled ‘Chain Reactions and Interactions’ looked at the large number of developments in the pharmaceutical sector within...
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Understanding MDR: 8 Important Changes
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations will bring about many changes compared to the current regulatory framework. We look...
Acorn Regulatory To Speak at RQA Ireland Forum 2019
We will be speaking at the 2019 RQA Ireland Regional Forum on May 23rd at The Kingswood Hotel in Dublin. The 2019 event will focus on the theme of ‘Chain Reactions & Interactions’ and will look at the uncertainty that...
What We Have Learned About Work Flexibility at Acorn Regulatory
Acorn Regulatory’s ability to offer flexibility to staff has helped it to attract and retain some of the most talented people in our sector. Brian Cleary looks at work flexibility and the options that we enable our staff to take.
The February 2019 Acorn Regulatory Newsletter
Welcome to the first newsletter of Spring! In the February 2019 newsletter we are looking at the issue of scientific literature,the common variation validation issues, looking back at some of the most read articles on our site and much more. ...
The January 2019 Newsletter from Acorn Regulatory
Is it too late to wish you a Happy New Year? We hope not. Welcome to the January 2019 of our monthly newsletter. This year is going to be an interesting year with so much happening that will impact on...
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