Nuala F. Calnan PhD

CEO, Biopharm Excel Ltd

Nuala Calnan is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author, and commentator is directed toward the delivery of patient-focused excellence and has included research for the FDA, HPRA (Ireland), and other regulatory agencies on patient safety and product quality in the manufacture and distribution of drugs. Her current areas of consultancy and research include quality risk management, building patient-focused quality cultures, data integrity, knowledge excellence, designing 'Metrics that Matter' and cost of quality. Nuala co-leads the ISPE Cultural Excellence Team, is a founding member of the ISPE/PQLI Task Team on Knowledge Management and was Technical Author of ISPE's Advancing Pharmaceutical Quality (APQ) Guide Series.