Acorn Regulatory April 2019 Newsletter

In the April 2019 newsletter we look at one of the most popular articles in recent years on our website. We have updated ‘What Are The Initial Steps in Applying for a Marketing Authorisation?’ to reflect changes in legislation. In this edition of the newsletter, we also look at one of the upcoming events that we will be presenting at, articles from previous newsletters that you might have missed in ICYMI (In Case You Missed It) and more.

UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?

In this blog we look at the initial steps that need to be taken when applying for a marketing authorisation for a pharmaceutical product within the EEA.

New Vacancy; Quality Specialist

As part of our ongoing growth, we are now recruiting for a further position. The Quality Specialist role is part of our expansion plans that were recently reported on by industry website MedTech Engine.

We have a diverse team of specialists who work with clients on issues such as clinical trials, advertising compliance, licensing new products for international markets and much more. Our practice areas include Pharmaceutical, Medical Device, Pharmacovigilance and Clinical Trials. Furthermore, we are constantly expanding as clients seek us our services to help them bring new products to market.

Find out more here.

Impact of Potential No-Deal Brexit Scenario on Medical Devices

Despite significant amount of negotiating netween the EU and the UK and within the UK parliament, the risk of a no-deal or cliff edge Brexit remains a very real possibility if the UK does not ratify the Withdrawal Agreement. There are several key areas for medical device companies to consider in terms of impact to their business in the event of a no-deal Brexit scenario. We wish to highlight here two areas for consideration for the medical devices sector.

Have You Seen Our Latest Vacancies?

We are a growing regulatory affairs consultancy company. Right now, we are recruiting for experienced individuals in a number of our teams. Check out of latest vacancies here.

Acorn Regulatory To Speak at ‘Manufacturing Excellence’ 2019

Experts from Acorn Regulatory will be presenting at the ‘Manufacturing Excellence’ event at the Questum Centre, Clonmel, Co. Tipperary on May 29th next. This is the second time in recent years that Acorn Regulatory has presented at the event and this presentation will be an update on the ‘Developments in Regulatory Affairs’ event held in February 2016.

You can book to attend here.

#ICYMI

Welcome to this month’s edition of #ICYMI – looking at articles from the Acorn Regulatory archive that you might have missed when they were first published.

This month we are looking at the Worksharing Procedure, RMP’s (Risk Management Plans), the need for Key Performance Indicator’s in Pharmacovigilance and how you can better prepare for a PV inspection.