Frank Hallinan, Prof., PhD Consultant

Frank is an accomplished Quality Management Professional with over 30 years of global experience in the biopharmaceutical industry. He has served as the CEO of the Irish Medicines Board (IMB) and worked in senior management roles in Quality, Regulatory Affairs and Analytical Development with Schering-Plough, Wyeth/Pfizer and most recently as SVP/Global Head of Quality with Jazz Pharmaceuticals. This included 7 years as the site Quality Head through the startup of the major Pfizer Grange Castle, Ireland facility.

As an international consultant, Frank has assisted several organisations (public and private) in various countries in understanding current biopharmaceutical quality requirements, in managing deviations, investigations, corrective & preventive actions, and change controls, and in implementation of a Quality System aligned with Q9 and Q10.

Frank served as the Founding President of the Ireland chapter of PDA from 2005 to 2007 and led the organization of a joint PDA/IMB meeting at the Dublin ESOF 2012 meeting on the topic of Advanced Therapies.

Frank is qualified as a QP through a Post Graduate Diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin. He holds a BSc in Biochemistry and a Ph.D. in Cell and Molecular Biology from UCC, Cork, Ireland and the University of Southampton, UK, respectively, and is currently an adjunct Professor at the School of Pharmacy of UCC, Cork.