Regulatory Science Ireland (RSI) Seminar, Cork, 8th September 2015
Ivowen Limited recently attended the Regulatory Science Ireland (RSI) Seminar hosted by Dr. Kevin O’Donnell (HPRA) and Professor Caitriona O’Driscoll (School of Pharmacy, UCC), which was followed by a round table interactive Q&A session.
RSI is a new organisation that carries out research and education in the field of pharmaceutical regulatory science and is made up of a network of interested parties ranging from:
• Regulatory Body (HPRA)
• Pharmaceutical Industry
• Medical Devices Industry
• Government Agencies (Enterprise Ireland, Science Foundation Ireland, Industrial Development Authority)
The development of the discipline of regulatory science has been realised as a result of the ever increasing complexity of healthcare products and the requirement of a data driven evidence based approach to their regulation in the areas of quality, safety and efficacy throughout the lifecycle of a medicine. The FDA has already established Centres of Excellence in Regulatory Science and Innovation (CERSIs) and are collaborations between FDA and academic institutions to advance regulatory science through innovative research, education, and scientific exchanges. RSI is committed to the development of an integrated Irish response to the global regulatory science effort in the fields of:
• Education and Training
• Knowledge sharing
RSI will provide an effective response to the increasing complexity of healthcare products and their associated regulatory systems and will create a cohort of Irish based regulatory science experts.
Ivowen Limited will attend further RSI Symposia later this year and in 2016, location and venues to be confirmed. See the RSI website for further information www.regulatoryscienceireland.com.
Written by Laura Oakey