Ann Mcgee

Biography

Ann qualified as a pharmacist from Trinity College Dublin in 1983 where she also obtained a research M.Sc in Science, working in the area of pharmacognosy. Ann has more than 30 years’ work experience divided between the pharmaceutical industry and as a regulator. Ann’s industrial experience spans the areas of Clinical Trials, Regulatory Affairs, Product Development, Quality Assurance and Regulatory Compliance, Technical Management and as a Qualified Person. As a regulator, Ann worked as a Senior Inspector with the Health Products Regulatory Authority (HPRA, formerly the Irish Medicines Board) and inspected nationally and internationally on behalf of the EMEA for GxP compliance. Ann acted as Registrar and Secretary (CEO) of the Pharmaceutical Society of Ireland, the statutory body governing the profession of pharmacy in Ireland. The remit of the Society includes the education and registration of pharmacists and the monitoring and enforcement of standards of Good Pharmaceutical Practice. Her varied and extensive experience equips Ann with an in-depth knowledge of Quality Management Systems and of the regulatory compliance standards and requirements across all area of best practice (GxP). Ann has actively participated at national and international level in initiatives impacting the healthcare area including the development of legislation and GMP guidance impacting the pharmaceutical sector. She was elected and acted as Vice-Chairperson of the PIC/S and took an active part in the development of a number of PIC/S guidance documents, some of which have since become annexes to the EU GMP Guide. Ann has obtained a number of additional qualifications in various subject areas of interest during her career to date and is firmly committed to her own continuing professional education. She is a member of a number of professional associations including ISPE and The Pharmaceutical and Healthcare Sciences Society (PHSS). She is also a member of the Committee of the Irish Chapter of the Parenteral Drug Administration (PDA) and of the European QP Association Expert Panel on GDP. Ann won the Services category, Small Firms Association National Awards 2013. She was also named the Enterprise Ireland WMB Female Entrepreneur of the Year 2012.

Research Interest

pharmaceutical industry and as a regulator