Overview of EU Regulatory Framework – Acorn Regulatory Presents at Industry Event

In the first Manufacturing Excellence event of 2016 held by County Tipperary Chamber on 12th February, Dr. Gemma Robinson (Managing Director of Acorn Regulatory) presented to a room full of Regulatory, Human Resource and Manufacturing Managers on  ‘The Latest Developments in Regulatory Affairs’. This event coordinates science and manufacturing professional to come together to discuss best practice and issues.Gemma Robinson at the Manufacturing Excellence event

Dr. Robinson focused on the development of the EU Legislation within the Pharmaceutical and Medical Device sectors, concentrating on the evolution of this landscape over the recent years. This included changes to the Pharmaceutical legislation and an overview of the expected changes to the Medical Devices; processes and new technologies. These have all helped to streamline the regulatory process and ensure patient safety is at the core of every stage from manufacturing, to clinical trials, to commercial availability.

Dr Robinson also touched on the issue of Pharmacovigilance and how the new legislation and responsibility of the QPPV has developed, to help monitor the safety profile of products coming to market and on the market.

The Manufacturing Excellence presentation was very well received, with a discussion that followed on the many challenges in the Regulatory and Manufacturing environment for the coming years.

Following the presentation there was a lengthy questions and answers session chaired by Clonmel & County Tipperary Chamber CEO Brian Cleary.  Among the issues covered were the possibility the the UK might leave the EU, the changeover from paper based submissions to electronic submissions and more.

If you would like to discuss this issue further with us, then please call us on 00353 52 61 76706 or complete your details below.

Further Reading from Acorn Regulatory

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.



About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD