Acorn Regulatory to Present TOPRA Webinar on Northern Ireland Protocol

Janet Fitzgerald, Regulatory Project Manager at Acorn Regulatory, will present on the consultancy approach to the Northern Ireland Protocol in a TOPRA webinar on March 4th at 1.00 pm.

The presentation will focus on experiences dealing with the impact of the NI protocol on UK National MAs, and how EU and MHRA guidance has impacted products in NI and GB in practice.

This will be followed by a question and answer session.

UPDATE:  The event is now fully booked and a lengthy waiting list is in place.  However, you can request a PDF of the slides from the event.  The slide deck will be sent after the event on March 4th, 2021.

Get The Slide Deck

Further Reading from Acorn Regulatory

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.

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.

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about it here.  5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.

Read the full article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance, and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.

Download the e-book here.

A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail.

Read more here.

Download Our Northern Ireland Protocol Pharmaceutical Guide

How will the Northern Ireland Protocol impact companies in the pharmaceutical sector?  That is a question that we have been asked many times in recent months.  The issue of the Northern Ireland Protocol has continued to be a source of disquiet and uncertainty for life science companies.  With that in mind, we have created a brief guide on the protocol.

Read more here.