Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST), in the Dublin Institute of Technology, where she also lectures, and is Director of the several MSc. and BSc. Pharmaceutical Programs. Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector, in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently Secretary of the Irish Chapter of PDA. Anne is also on the Board of Directors of Regulatory Science Ireland (RSI), leading the Education & Training development group.
Nuala Calnan is the Chair of the RSI Organising Committee for this Scientific Symposium on Knowledge Management and has over 20 years experience in the pharmaceutical industry including roles at Leo Pharma, Elan, Wyeth BioPharma (Pfizer), PM Group and is currently a member of the Pharmaceutical Regulatory Science Team at DIT, Ireland.
Nuala was an author on the ASTM E2500-07 and several other industry guides on Science and Risk Based Approaches and is currently a member of the ISPE’s Quality Metrics Pilot team and is leading the Quality Culture sub -team for that group.
Nuala holds a BSc.(Eng), an MBA and is currently working on her PhD in Regulatory Science, researching the integration of Excellence, Knowledge & Culture in delivering enhanced quality outcomes for the patient and has led an Irish Industry research study in this field. Her work has included the development of a Leading Quality Indicator (LQI) metric tool designed to measure changes in workplace behaviours that can influence quality culture and the publication of an e-journal on Knowledge Management in May 2014. In 2015, Nuala will commence the first RSI post-doctoral research project to analyse the Product Recall and Quality Defect data at the HPRA, Ireland.
Kevin O’Donnell, Ph.D. is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the IMB). He is responsible for a number of compliance-related and market-surveillance programs at HPRA, such as the quality defect and recall program and its sampling and analysis activities. Kevin is also a senior GMP Inspector at the HPRA. He
obtained his PhD in the field of Quality Risk Management from the Dublin Institute of Technology, Ireland, in 2008.
Paige Kane, is a Certified Pharmaceutical Industry Professional (CPIP) and the Director of Knowledge Management Pfizer Global Supply (PGS) – Global Technology Services. In her current role, she is responsible for developing and implementing the Knowledge Management Strategy for Pfizer Global Supply (PGS) with a strong focus on people, collaboration, and processes. Paige has over 25 years experience working in a regulated environment (including Genetics Institute, Wyeth, Monsanto and the US Government). Ms. Kane has been responsible for developing and implementing Quality Systems for GLP, GCP and GMP, as well as, Computer System Validation programs. In addition, she provided leadership and Subject Matter Expertise for multiple biotech startups in the US and Europe.
Ms. Kane is currently a member of the ISPE Strategic Forum and the Chair of the ISPE CoP Council. She has served/led multiple ISPE Steering Committees (Americas and Europe) since 2002 and has been a contributing author to several GAMP good practice guides. Ms. Kane is currently pursuing a PhD at Dublin Institute of Technology with a focus on Knowledge Management as an enabler of ICH Q10.
Gerry Creaner has over 30-years of experience in the Life Sciences manufacturing industry across a range of technical, managerial and business roles. A Chemical Engineer by profession, he has extensive international experience having lived and worked in Asia for 6-years and is currently based in Boston MA. He established a very successful engineering consultancy prior to founding GetReSkilled, an online education and learning business focussed on the increasing demands to protect public health through the manufacture of high quality, safe and effective medicines – with particular emphasis on developing these competencies within the operator and technician groups who come into direct contact with the product across the global manufacturing supply chain.
Kelly is currently Manager, Global Quality Risk Management at Sanofi. She is responsible for the design, deployment, and continuous improvement of the Quality Risk Management program throughout manufacturing and GMP operations at Sanofi. Kelly has extensive industry experience in microbiology, product release, change control, deviations/ investigations, CAPA, and risk management. Based in the US, Kelly received her BA in Biology from Boston University (Boston, MA) in 2003 and her MBA in Pharmaceutical Management from Fairleigh Dickinson University (Madison, NJ) in 2008. She is currently pursuing her PhD in Quality Risk Management from the Dublin Institute of Technology in Ireland.
Joe Brady is a bioprocessing consultant to the biopharmaceutical, aseptic processing and blood-plasma processing industries. Joe is also a lecturer with the Dublin Institute of Technology in the School of Chemical and Pharmaceutical Sciences. Joe has particular specialties in engineering design, process validation, computer system validation and regulatory affairs. Joe has a BSc and a PhD in biotechnology, and has over 20-years project, operational and training experience in the pharmaceutical, biopharmaceutical, blood-plasma and medical device industries globally.
Elaine Harris has over 20-years of experience in the Life Sciences industry across a range of technical, managerial, business and consultancy roles. Following a PhD in bio-inorganic chemistry, she worked in the pharmaceutical industry for 9 years in new product development and technology evaluation. Since establishing her own consultancy company in 2002, Elaine has focused on the pharma, bio-pharma and medical device industries and has provided consultancy services to academics, companies and government agencies active in these sectors. Elaine also a lecturers with the Dublin Institute of Technology in the School of Chemical and Pharmaceutical Sciences and has supervised over 40 MSc students with a particular research focus on the areas of Knowledge Management, PAT, clinical trials and the use of social media.