Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)
The new veterinary medicines regulation (Regulation (EU) 2019/6) will come into force in January 2022. It will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union. The new regulation seeks to simplify the...
Download our Clinical Evaluation Report Slide Deck
The most significant change from the MDD to the MDR is the increased focus on clinical evaluation, access to data, and post-market surveillance. This places a greater burden upon manufacturers and their representatives, and it is something that we, at...
Download ‘Regulatory Intelligence 9’ from Acorn Regulatory
‘Regulatory Intelligence 9’ from Acorn Regulatory has a wide range of articles covering issues such as Brexit, the new Medical Device Regulations, DCP Close Outs, and more. The articles in ‘Regulatory Intelligence 9’ have been written by members of our...
The Acorn Regulatory Brexit Guide No. 1 Revised for 2020
We published our first Brexit guide in July 2016. Back then, we looked at the potential implications for the life sciences sector. Now, we know much more about how Brexit will look at the moves that companies need to take...
What Are Post-Marketing Surveillance Studies?
Post-marketing surveillance studies are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures. In this article we...
Pharmacovigilance of Medicines for Rare Diseases
We look at the issue of pharmacovigilance for orphan or rare diseases. Many issues associated with the sector are challenged by the small patient population. This article looks at the commonly used strategies for evaluation of post-approval safety and the...
Veterinary Clinical Trials: New EU Law & Global Approaches
Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a...
How To Write An Effective CER
The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in...
Download Our Clinical Trials E-Book
Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland. Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market. The...
Updated for 2020: A Practical Approach to Risk Management Plans
Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European...
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