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.
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.
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Further Reading from Acorn Regulatory
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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.
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