‘A Guide to European Pharmaceutical Regulations for Human Medicines’ by Cliodhna McDonough
Publication due: September 2019
The life sciences industry represents one of the dominant economic sectors in the UK. Given the complexity of the European Regulatory Framework relating to the supply of human medicinal products this book gives an authoritative overview of the law as it currently stands.
This practical guide will address the regulatory procedures and day to day challenges for the authorisation and use of human medicinal products in the EU’s most regulated industry.
User friendly, practical and pragmatic this book will prove an invaluable source of information for those who work in industry, regulatory authorities and for all persons who need to familiarise themselves with the relevant legislation in this fast moving industry sector.
ABOUT THE AUTHOR
Cliodhna Mc Donough is a highly respected life sciences legal practitioner with Stephenson Harwood LLP London.
In addition to her work as a regulatory lawyer Cliodhna uniquely holds dual professional qualifications and hands on practical scientific experience having worked in both a medical setting in her capacity as lead hospital clinical dietitian and internally with companies such as L’Oréal and Roche Pharmaceuticals.
Cliodhna shares her sector knowledge as board member of the Masters of Science EU Regulatory Affairs Degree at the University of College Dublin and was also appointed by the Irish Minister of Health in 2013 to the Government State Board CORU which regulates Health Care Professionals.
Cliodhna has been described by clients as “first class at solving complex scientific technical issues with a pragmatic approach” and is a regular contributor to Pharmaceutical journals and discussions with both national and international government regulatory agencies with regard to regulatory governance and life sciences industry innovation.