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...
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 ArticlesClinical & MedicalFeatured NewsGemma RobinsonPharmaceutical
FDA Seeks Input on New Technology for Conducting Clinical Trials
Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting clinical trials. As clinical trials continue to evolve, the FDA wishes to identify new opportunities to study investigational products and...
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 to Exhibit at Med in Ireland – Dublin, October 29th 2015
Med in Ireland – October 29th 2015, Dublin Convention Centre, Ireland Acorn Regulatory is delighted to attend the Med in Ireland conference and exhibition on October 29th 2015. This biennial event is Enterprise Ireland’s largest medical technologies event, bringing together...
DCP Applications To Be Accepted Only in eCTD format from July 1st 2015
Looking back on how far we have progressed from the standard paper submission one thing is clear – the age of the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersQuality Management SystemTraining
Conducting Internal Audits – Guidance from our Quality Team
Our quality team has a well deserved reputation for excellence. In this blog they share their thoughts on what you need to do when conducting internal audits at your facility. Guidance on conducting Internal Audits – ISO 9001:2008 ISO 9001:2008 8.2.2...
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