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 providing scientific, toxicological, and regulatory support to ensure appropriate risk management. She conducts safety assessments for various administration routes, using computational and read-across methodologies as needed. Erika is a member in internal cross-functional teams and committees, as well as external consortiums such as the Safety Working Group within ELSIE. Previously, she worked as an occupational toxicologist, compiling 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 1: February 27th, 2025
SESSION: Safety assessment of E&Ls: toxicology assessment workflow and challenges with different administration routes
◆ Introduction to general safety and regulatory considerations for extractables/leachables (E&Ls) in pharmaceutical products.
◆ Considerations for different administration routes, including (topical) ocular.
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).
