Danica Cvetkovic

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more