Kerona Team Member: Dr. Irene McGrath

Dr. Irene McGrath

Irene has extensive experience in regulatory affairs and management of product development programmes, gained through working in private industry and consultancy for close on 30 years. Irene’s reputation means that she is much sought after not only as a regulatory consultant but also as a trainer and speaker with an international reputation. Irene has a B.Sc. in Analytical Science and a Ph.D. in Chemistry from Dublin City University. She began her career in the plant protection industry working on the development and validation of analytical methods for five batch analysis. Irene moved into regulatory affairs in 1994 and in 1999 founded a leading international consultancy, where she worked as the principal regulatory consultant for 10 years on a wide range of projects for task forces and individual clients from the plant protection, biocide and chemicals (REACH) sectors. Following this, Irene worked in strategic regulatory roles in private industry, managing Annex I Renewal (AIR), data matching and product authorisation programmes, before founding Kerona Scientific Ltd. in 2014. Over the years, Irene has submitted notifications and dossiers for review of active substances under both the plant protection and biocides review programmes (Regulation 1107/2009 and the BPR), and more recently on Annex I renewal of existing authorisations (the ‘AIR’ projects). A former Vice-President of the European Crop Care Association (ECCA), she has considerable experience in data matching, data access negotiations, task force management and developing alternative packages for data protected substances. At Kerona, Irene provides strategic regulatory advice to clients on new product introduction (NPI) programmes, from concept through to marketing, and on the optimisation of existing portfolios, including biocidal product family and Union Authorisation approaches. Irene has developed and published Kerona’s BPR Vademecum and CLP Companion, which are being used by competent authorities and industry alike. She has designed and delivered numerous training sessions and programmes in plant protection, biocides and other key regulatory topics. Irene speaks French and Spanish and has developed strong relationships with competent authorities throughout the EU over many years.