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 over 26 years. Irene’s reputation means that she is much sought after not only as a regulatory consultant but also as a trainer 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, 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 lists 1 – 4 of the original EU review programme under Directive 91/414/EEC, and for biocides under 98/8/EC, and more recently on Annex I renewal of existing authorisations (the ‘AIR’ projects). A former Vice-President of 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, which is 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.
Catherine is a specialist in regulatory toxicology, human health exposure modelling and risk assessment, physical-chemical properties and analytical methodology. Catherine has a B.Sc. in Chemistry from the Applied Sciences University (Jordan) and an M.Sc. in Analytical Toxicology from the University of Jordan. She has a broad range of scientific experience including laboratory management and HPLC, AAS and UV instrumentation. She began working in 2005 in an international feed manufacturing firm as laboratory manager and was responsible for obtaining laboratory accreditation and introducing HPLC instrumentation. She moved into regulatory affairs in 2007 working as a consultant with leading international consultancies specialising in agrochemical, biocide, REACH and cosmetics registrations. Catherine has significant experience in reviewing scientific data, data gap analysis and dossier preparation in these sectors as well as poison centre notification. At Kerona, Catherine focuses on exposure modelling and risk assessments for biocides, plant protection and REACH using ECHA’s Biocides Human Health Exposure Methodology, ConsExpo, EFSA’s Guidance and calculator, ECETOC, ART and RISKOFDERM as well as specialised modelling and argumentation for special cases. Catherine speaks Arabic and has dealt with regulatory authorities worldwide, and she is the main contact point for submissions to the Middle Eastern region.
Susan is an expert in Phys/Chem, Analytical Methodology and Environmental Modelling. Susan has a B.Sc. in Analytical Science from Dublin City University and an M.Sc. in Environmental Chemistry from University College Cork. She has extensive laboratory experience having worked as a research chemist for the Centre d’Etude et de Valorisation des Algues in Brittany, France, and as a laboratory chemist in both the pharmaceutical and environmental sectors. She began working as an environmental consultant in 1998 where she was involved in both sampling and analysis of wastewaters for IPC and local authority licensing. She moved into regulatory affairs in 2001 working as a consultant with a leading international consultancy specialising in agrochemical and biocide registrations. Susan has considerable experience in data gap analysis, study commissioning, monitoring of field trial programmes and dossier preparation. Susan is our key expert for biocides registrations. She is currently responsible for strategic mangagement of biocidal product authorisations at Kerona. Her work includes biocidal product dossier preparation using the key IT tools and study coordination of biocidal product testing with respect to storage stability and efficacy evaluation. She also manages environmental risk assessments for biocidal products using the EUSES model. In the area of plant protection, Susan is experienced in Article 43 renewals, mutual recognition applications, technical equivalence and environmental modelling for plant protection products using FOCUS and national methodologies. Susan speaks French and also manages the plant protection programmes for the Southern European region.
Jim has a B.Sc. in Microbiology and a Diploma in Computer Science, both from University College Cork. His early career experiences included periods at a medical device sterilisation company and in the environmental department of a local authority, where his activities ranged from laboratory work at a water treatment plant to designing a software package for monitoring small water supply schemes. Jim spent 14 years working in the Dublin branch of a major U.S. reference publishing company, as a senior editor, abstract writer and indexer of a wide range of academic and popular scientific periodicals, with a particular emphasis on biological and chemical topics but also covering subjects as diverse as climatology and mathematics. An accredited member of the U.K. Society of Indexers, he has recently worked as a freelance book indexer. Within the Kerona team Jim is the key contact for literature searches and for fertilisers, plant biostimulants and biopesticides. Jim specialises in the residue and efficacy sections of the plant protection dossiers, risk assessments for soil organisms (micro-organisms, earthworms and non-target arthropods) and dossier preparation for microbials. He is also involved in preparing biocidal product dossiers using the ECHA IT tools, commissions efficacy studies for biocides, and is responsible for updating Kerona’s BPR Vademecum.
Ieva has a degree in Chemical and Pharmaceutical Sciences from Dublin City University, and has worked as a process and environmental scientist for a global pharmaceutical company. At Kerona, Ieva specialises in the environmental and ecotoxicology sections of plant protection dossiers, commissioning and monitoring studies and preparing study summaries and risk assessments for EU dRR dossiers. Ieva is a native Lithuanian and Russian speaker, and manages applications to the Baltic and Northern European regions.
Barbara has a Masters Degree in Marine Biology from the University of Gdansk in Poland. During her studies, she was heavily involved in marine research with the Institute of Oceanology Polish Academy of Science in Sopot with a focus on arctic ecosystems. She is an experienced environmental consultant who has worked with various global companies on marine environmental survey provision, environmental impact assessments and statements, environmental monitoring studies and project management. She has extensive experience in laboratory work which has involved identification of marine and freshwater species. At Kerona, Barbara specialises in ecotoxicological risk assessments and exposure assessments. She manages study commissioning programmes for ecotoxicology studies and prepares study summaries and risk assessments for ecotoxicology dossier sections. Barbara is a native Polish speaker and manages applications to the Central European regions.
Dr. Neus Rodriguez Sanchez
Neus has a B.Sc in Biological Sciences and an M.Sc. in Aquaculture, both from the University of Valencia in Spain. She began work as a research laboratory technician and was responsible for conducting toxicity tests with fish embryos and molecular assays. She completed her Ph.D. at Liverpool John Moores University in collaboration with the Norwegian Institute for Water Research. The Ph.D. focused on the development of computational approaches (e.g. QSARs, structural alerts) and in vitro methods to assess the toxicity and bioaccumulation of organic chemicals in aquatic organisms. Neus spent 3 years working as a regulatory ecotoxicologist for the UK’s Chemicals Regulation Division, where she was responsible for the registration of plant protection products and biocides in the Central European zone. At Kerona, she specialises in risk assessments for ecotoxicology dossier sections and the prediction of toxicity endpoints for use in a regulatory context. Neus is a native Spanish speaker and manages applications to the Southern European region.
Emma is the Office Manager supporting the regulatory team. Emma has a broad range of experience in office management, human resources and finance from a wide variety of industries including telecoms, voluntary, NGO/government bodies, manufacturing and service provision. Emma is a CIPD member and holds qualifications in HR, Finance, Management and Customer Service disciplines. Emma has a proven track record in identifying opportunities for refining and streamlining work processes and applying ‘working smarter’ principles. In addition to general office management skills Emma also has experience in Client Management; maintaining and growing existing business relationships as well as developing relationships with new clients, ensuring all of our clients experience excellent and innovative customer service.
Vacancy for a Regulatory Consultant – this could be you. Please see our Vacancy page for more information.