Brexit: The Implications on Existing Marketing Authorisations
In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations.
MHRA Moving Towards Paperless Communications
Following discussions with industry bodies, the MHRA is now replacing all paper-based communications with emails. The emails will replace paper-based communications about Common European Submissions Portal (CESP) submissions. Companies working with the MHRA will now receive emails to a single address...
Industry News Roundup: August
We are looking at five of the biggest stories in the pharmaceutical, medical devices and clinical trials sectors in the past month. Each month we will seek to highlight 5 key stories in trade publications and newsletters. This month we...
The Implications of Brexit on the Pharmaceutical, Medical Devices & Clinical Trials Sectors
Acorn Regulatory has published a whitepaper looking at the potential implications of Brexit on a number of healthcare sectors. The document looks at the impact of the UK’s decision to leave the EU on institutions such as the EMA. It also...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalRisk Management
Risk Management Plans – What You Need To Know
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 Risk Management Plan will include an Action Plan outlining risk minimisation activities that are...
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...
