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...
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...
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...
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Download ‘Regulatory Intelligence 6’ Now
‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.
What Are Post Authorisation Safety Studies?
Post authorisation safety studies (PASS) 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...
Will Clinical Trials Be Impacted By Brexit?
How will clinical trials be impacted by the UK’s decision to leave the European Union? The United Kingdom’s decision to leave the European Union (EU) will present significant implications to the pharmaceutical industry. Clinical trial sponsors and associated partners should...
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The Risk of No Deal Increases – ‘What Happens Next?’ – The 7th Acorn Regulatory Brexit Whitepaper
The seventh Acorn Regulatory Brexit whitepaper looks at the impact of a no deal departure from the EU on a number of sectors.
