The February 2019 Acorn Regulatory Newsletter

Welcome to the first newsletter of Spring! In the February 2019 newsletter we are looking at the issue of scientific literature,the common variation validation issues, looking back at some of the most read articles on our site and much more. We also have another opportunity for you to download ‘Regulatory Intelligence 5’ which is our latest e-book.

Regulatory Intelligence 5 – Just Published

We have published our latest e-book ‘Regulatory Intelligence 5’. This edition features a number of new articles from our expert staff. In this fifth edition of our e-book series we will look at GVP and Social Media in a 2019 update of one of the most read articles ever posted on our website. We also look at a range of other issues. You can download it by clicking here.

The Increasing PV Obligations of Scientific Literature

Scientific literature is a significant source of information for the monitoring of the safety profile of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. However, the monitoring of literature with respect to pharmacovigilance is a huge undertaking, involving investment of excessive time, effort and cost for sifting through high volumes of multi-disciplinary journals. Read more here.

What Are The Common Variation Validation Issues? Find Out Here

Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations and the critical issues that you need to be aware of when completing a variation.

We Are Hiring: Pharmacovigilance Advisor (Office or Remote Based within Ireland)

2019 is proving to be every bit as busy as 2018. Now, we are seeking to recruit an additional Pharmacovigilance Advisor to growing PV team. You can read more about the role and what it is like to work at Acorn Regulatory here.

Acorn Regulatory At Paris Sud University

Dr. Gemma Robinson, Managing Director of Acorn Regulatory was recently invited to present to the Pharmacy faculty students at Paris Sud University. The presentation covered many aspects of regulatory affairs including recent legislative changes and Brexit. Acorn Regulatory staff members are frequently called on to speak at industry events. Read more about some of the upcoming events in the Acorn Regulatory calendar here.

#ICYMI

In this first ICYMI In Case You Missed It) of 2019 we look at four articles from the Acorn Regulatory archive. We look at CE Marking a medical device that contains a medicine, the difficulties associated with Type I variations, the issues surrounding non EU dossier’s and we provide an overview of PSUSA’s.