Acorn Regulatory NewsBrexitChristine McGrathClinical & MedicalDanica CvetkovicGemma RobinsonMarie CarrollMarketing Authorisation HoldersPharmacovigilancePublicationsRegulatory Strategy
Download ‘Regulatory Intelligence 6’ Now
‘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.
Most Read Pharmacovigilance & Medical Articles of 2019
Our pharmacovigilance and medical teams have had a busy 2019. During the course of the year they have taken the time to write some very well received articles about PV, medical and clinical issues. Here, we have compiled 4 of...
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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...
‘PV Update’: Get Our Pharmacovigilance E-Book Now
Acorn Regulatory’s pharmacovigilance and medical teams work with some of the largest and most dynamic companies in the world. They have looked at the major issues impacting their clients at the moment and have created ‘PV Update’ which is our...
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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.
The UK PSMF – What Will It Look Like?
How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU? What actions will companies with a UK Marketing Authorisation Holder (MAH) need to take in the event of a no-deal Brexit? We consider...
What Are Post Authorisation Safety Studies?
Post authorisation safety studies (PASS) are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures. In...
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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‘Selected Writing from Acorn Regulatory’ Download It Here
‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months. This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory. Download it...
‘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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