Changes to ISO 9001
At Acorn Regulatory we are committed to ensuring quality in all aspects of what we do so it’s vital to us to stay informed of updates in legislation, requirements or standards in our field of expertise – quality and regulatory....
EMA Introduces New Chapter on Good Pharmacovigilance Practices (EU-GVP)
The European Medicines Agency has added a new chapter (Product- or population-specific considerations II: Biological medicinal products) to its guidelines on good pharmacovigilance practices – EU GVP. The new GVP guidance comes into force on August 16th 2016. The new chapter...
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.
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...
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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...
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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...
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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...
