Ira Koval, PhD ERT

Ira Head is currently head of the Regulatory Affairs department at Charles River Laboratories. She joined the Regulatory Affairs department at Charles River Laboratories in 2015 and worked as a Section Head of Global Regulatory Consultancy group within the department until 2020, when she left the company to work as a scientific non-clinical assessor at the Dutch Medicine Evaluation Board (CBG-MEB). During her working period at CBG-MEB she was serving as a member of Nitrosamine Safety Operational Expert Group (NS-OEG) of European Medicine Agency. In this role, she contributed to the development of the Carcinogenic Potency Categorization Approach (CPCA) for nitrosamine impurities in human medicines and has co-authored the article on CPCA development and application (Kruhlak et al., Regulatory Toxicology and Pharmacology, 2024, in press). She rejoined Charles River in April. 

Ira is a European Registered Toxicologist and holds a Ph.D. in bioinorganic chemistry from Leiden University (The Netherlands). Her scientific interests include non-clinical toxicology and pharmacokinetics, structure-activity relationships and QSAR methodologies, as well as various regulatory frameworks (crops and chemicals, pharmaceuticals).  She is a co-author of more than two dozen scientific papers published in international recognized journals.