Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDFeatured NewsGemma RobinsonPharmacovigilance
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...
Acorn Regulatory NewsFeatured NewsGemma RobinsonPharmaceuticalPharmacovigilanceQuality Management SystemRegulatory Affairs
Overview of EU Regulatory Framework – Acorn Regulatory Presents at Industry Event
In the first Manufacturing Excellence event of 2016 held by County Tipperary Chamber on 12th February, Dr. Gemma Robinson (Managing Director of Acorn Regulatory) presented to a room full of Regulatory, Human Resource and Manufacturing Managers on ‘The Latest Developments in...
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.
2015: Good Pharmacovigilance Practice (GvP) and Social Media
Editor’s Note: This article about GvP and social media is one of the most read articles ever on our website. With that in mind, we updated it in 2019 to take into account the myriad changes that had occurred in...
Acorn Regulatory's Top 100 ArticlesComplianceIVD DevicesMDD DevicesMedical DevicesPharmacovigilanceRegulatory Affairs
EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions
In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD and medical device manufacturers. In this article, we are going to delve a bit deeper and answer some questions about vigilance...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesPharmacovigilance
EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’
If you are a manufacturer of an IVD or a medical device, once your product is on the market, you must have an effective system for reviewing and evaluating customer complaints and product issues for any safety concerns. The European...
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