Alina Martirosyan
Sr. Scientific Manager Toxicology
Dr. Alina Martirosyan is experienced in non-clinical evaluation of medical devices and pharmaceuticals. In her current role she is planning, coordinating, and managing non-clinical studies for pharmaceuticals and medical devices, performing toxicological risk assessment of chemical constituents. She holds a PhD degree in Biochemistry, is a European Registered Toxicologist (ERT), Delegate of American Board of Toxicology (DABT), and is acting as an expert in ISO/TC 194 for the ‘Biological and clinical evaluation of medical devices’.
DAY 2: March 6th, 2026
SESSION: E&L in Medical Devices & Their Risk Assessment
◆ Biological Risk Assessment of Medical Devices within the Risk Management Framework.
◆ Role of Toxicological Risk Assessment in the Biological Risk Assessment.
◆ Toxicological Risk Assessment of Chemical Constituents of Medical Devices – Practical Application of ISO 10993-17:2023.
DAY 2: December 5th, 2024
SESSION: Toxicological Risk Assessment of Genotoxic Impurities: Derivation and Justification of Safe Limits
◆ Regulatory guidelines and position papers.
◆ Toxicological risk assessment of genotoxic impurities of medical devices.
◆ Parallels with toxicological risk assessment of genotoxic impurities of pharmaceuticals.
