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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 addresses 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 AUTHORCliodhna Mc Donough is a Legal Director at at a London based Law Firm specialising in Life sciences, Food and Medical Device Regulatory Law.In addition to her professional career as a Regulatory Lawyer, Cliodhna holds a BSc (Hons) in Clinical Dietetics and an MSc (Hons) in EU Regulatory Affairs. Previously, Cliodhna has worked internally for life science companies and as a lead Clinical Dietitian in a Dublin teaching hospital.Cliodhna shares her sector knowledge as both a lecturer and a board member of the Masters of Science EU Regulatory Affairs Degree at the University of College Dublin/University of Ulster 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 academic clinical and legal journals. She is frequently invited to join governance framework discussions with government regulatory agencies.
