Acorn Regulatory’s Essential Guide to Clinical & Medical Affairs

Our Clinical & Medical Affairs Services team works with companies all around the world and assists them with issues such as clinical trials, medical writing services, and medical information services.  They have also taken the time to write some of the most read articles on our website.  The Essential Guide to Clinical & Medical Affairs looks at the most read, downloaded and popular articles from the team in recent times.

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 this article, our Medical Manager, Dr. Danica Cvetkovic, looks at the PASS and the link with Risk Minimisation Plans (RMP’s).

Read more here.

Preparing the Reference Safety Information for a Clinical Trial

We look at the steps that companies need to take when preparing the reference safety information for a clinical trial. Read the full article here.

Carrying Out A Clinical Investigation Under MDR

As part of our ongoing series in advance of the MDR deadline, we are looking at clinical investigations and how they will operate after the MDR has been introduced. We have written extensively on the MDR issues and at the end of this article, you can access our range of whitepapers and other articles that look at the changes that the new regulations will bring about. Read the full article here.

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 veterinary clinical study involves research that gains information from animal patients.

Read more here.

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