The Latest Acorn Regulatory Newsletter

November 2020

We have 3 new e-books and guides for you to download in this newsletter.

The penultimate newsletter of 2020 looks at the issue of getting a Wholesale Distribution Authorisation for medicinal products.  This is an issue that we deal with consistently for client companies.  In recent years, we have been frequently asked to create a brief guide to the process and the WDA guide contained in this newsletter is the latest article in a series that we started in 2016.  We also have a download of our last new e-book of 2020: ‘Regulatory Intelligence 9’.  You can download by clicking the image below.  We hope that you find it useful.

Download ‘Regulatory Intelligence 9’

‘Regulatory Intelligence 9‘ from Acorn Regulatory has a wide range of articles covering issues such as Brexit, the new Medical Device Regulations, DCP Close-Outs, and more. The articles in ‘Regulatory Intelligence 9’ have been written by members of our expert team who work daily with some of the largest and most innovative pharmaceutical and device companies in the world.

Download the guide here.

NEW: Guide to The Northern Ireland Protocol

How will the Northern Ireland Protocol impact on companies in the pharmaceutical sector?  That is a question that we have been asked many times in recent months.  Now, as the UK’s departure from the EU gets closer, we have created a brief guide on the issue.  The guide answers some of the most commonly asked questions that we have received by email in recent weeks.

Get your download here

Obtaining a WDA from the HPRA

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 more here

What You Need To Know About the PRRC

This article is part of our series of MDR articles that look at the changes coming into play with the new medical device regulations.  In this article, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices.

Read more here

The Acorn Regulatory Brexit Guide No. 1 Revised for 2020

We published our first Brexit guide in July 2016.  Back then, we looked at the potential implications for the life sciences sector.  Now, we know much more about how Brexit will look at the moves that companies need to take to ensure that they can continue to supply their products to the UK and the EU.

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

Pharmacovigilance KPIs: How They Can Assist You

We created a comprehensive guide to MDR for attendees at the Irish Medtech ‘Global Access 2020’ event.  The event was held last week in Galway, Ireland, and virtually online.  Newsletter subscribers can get access to the e-book by clicking the link below.

Get your exclusive ‘MDR Insights’ guide here

Pharmacovigilance KPIs: How They Can Assist You

How important are pharmacovigilance KPIs in the effective management of a PV system?  We look at the issue and look at how to generate an effective evaluation of your pharmacovigilance system.  This article is an update to an article first written in 2017.

We consider issues such as the criteria that you should be using to determine your KPI’s and we look at the different types of indicators that you need to be aware of.

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.

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