Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesEileen ShortissFeatured NewsHow-To & ExplainersPharmaceutical
Medicinal Product Labelling: What You Need To Know
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
Steps to CE Marking an IVD Medical Device
One of the most frequent questions we are asked is: how do you CE mark an IVD device? We will look at the steps that you need to take to obtain when CE marking an IVD device. As the new...
Acorn Regulatory Wins Best Service Provider 2019
Acorn Regulatory won the ‘Best Service Provider’ at the third County Tipperary Business Awards which were held at the Clonmel Park Hotel on Friday, October 18th.
CMC Guidelines & More – #ICYMI from the Acorn Regulatory Archive
Each month we feature some of the excellent articles written by our expert staff that you might have missed. In this month’s edition of In Case You Missed It (#ICYMI) we look at the update to CMC guidelines, we impart...
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...
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...
ISO 9001:2015 – Audit Success for Acorn Regulatory
We are delighted to announce that we have successfully passed our ISO 9001:2015 annual surveillance audit conducted by NSAI on 24th March 2016. NSAI assessed our management system for its compliance with I.S. EN ISO 9001:2015 and found it to be...
Risk Management Plans (RMP) for Healthcare Companies
To address risk minimisation, Healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A RMP will include an Action Plan outlining risk minimisation activities that are carried out...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesClinical & MedicalFeatured NewsGemma RobinsonIndustry News
A Tightening of Regulations for Phase I Clinical Studies?
The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase (FAAH) inhibitors under investigation in the US. The investigation comes in the aftermath of a Phase I clinical trial in France, in which...
Congratulations to Eileen Shortiss
This week marked the 10th anniversary of one of our senior and much valued Regulatory consultants. Eileen Shortiss joined Acorn Regulatory back in 2006 when the company was much smaller than what it has become today. During her time with...
