The Latest Acorn Regulatory Newsletter

March 2021

Brexit is still a critical issue for companies in the medicinal products and medical devices sectors.  We are presenting on the issue of the Northern Ireland Protocol on March 4th (1 pm Irish time) along with industry body TOPRA.  The Protocol is an issue that is taxing the minds of many people in our sector and Acorn Regulatory Project Manager Janet Fitzgerald will be presenting on the issue.  You can get access to the webinar slides below.

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Get The Northern Ireland Protocol Webinar Slides

Acorn Regulatory is hosting a webinar on the Northern Ireland Protocol with industry body TOPRA today (March 4th).  The event is fully booked.  However, you can get the slide deck for the webinar, as soon as it is available, by clicking on the link below.

Get your slides by clicking here

Download Our CER 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 Acorn Regulatory, have been helping our clients with.  We have created a brief Clinical Evaluation Report Slide Deck that looks at how you can write an effective clinical evaluation report.  This slide deck will give you an overview of the measures that you need to consider when creating a CER for your medical device product.

Get the slide deck 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

MDR Regulatory Affairs Consultants

MDR (the medical device regulations) will present the most significant changes in the device sector for a generation.  Our MDR regulatory affairs consultants are ready to assist your company with any issues related to the new regulations.

Read more here

Do You Need A WDA? Here Is What You Need To Know

There has been an increase in the number of companies that have sought our services to assist them in obtaining a WDA.  If your company needs a WDA, we can assist you with the process in a timely and professional manner.  This blog from our Quality team looks at the issues that you will need to consider if you need a WDA.

Read the article 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.
Read the full article here.

Acorn Regulatory’s Pharmaceutical Team

Our pharmaceutical regulatory affairs team is staffed by experts who have considerable expertise in the sector.  Every team member has at least 15 years of experience in the pharmaceutical sector assisting pharmaceutical companies with their regulatory issues.  Since 2002, our pharmaceutical regulatory affairs specialists have been working with clients all over the world.

Read more here.