Erika Udovic
Senior Principal Scientist
Erika Udovic is currently working as a Senior Principal Scientist at Novartis with experience in human health hazard and safety evaluations of pharmaceutical impurities, including extractables and leachables. Her main responsibilities include scientific, toxicological, and regulatory support to ensure risk is appropriately managed. She provides safety assessments for various administration routes, applying computational and read-across methodologies where required. She is a member in internal cross-functional teams and committees, as well as external consortium (e.g., Safety Working Group within ELSIE). Prior to this, she worked as an occupation toxicologist responsible for compilation of risk assessment reports for drug substances, intermediates, and raw materials for worker and patient safety purposes. Erika has a background in Veterinary Medicine and found her passion in Toxicology.
DAY 2: MARCH 8th, 2024
SESSION: Safety assessment of E&Ls: challenges with different administration routes
◆ Introduction to general safety and regulatory considerations for extractables/ leachables (E&Ls) in pharmaceutical products.
◆ Considerations for ocular administration routes.
◆ Assessment strategies for intrathecal (IT) route of administration (tentative at this stage, might be adjusted later).
