Teresa Wegesser
Sr. Principal Scientist
Teresa Wegesser is a Principal Scientist at Amgen Inc. working as a nonclinical Project Team Representative on various cross-functional small and large molecule drug development teams since 2015. Teresa received her PhD in Pharmacology and Toxicology from the University of California, Davis where she focused her research on characterizing the pro-inflammatory and toxic potential of specific constituents of coarse particulate matter using in-vivo animal models. Prior to Amgen, Teresa worked in the chemicals industry as a Lead Toxicologist, identifying and classifying human health and environmental hazards, exposures and identifying/assessing/ mitigating potential human health and environmental risks of chemical additives in petroleum products. Teresa’s specialization is focused on safety assessments of impurities (non- and mutagenic), nitrosamines, and excipients.
DAY 2: December 5th, 2025
SESSION: Qualification of Non-Mutagenic Impurities
◆ Overview of approaches for qualifying non-mutagenic impurities.
◆ Key considerations from the EMA Draft Guideline on Qualification of NMIs.
◆ Establishing acceptable limits based on safety data and exposure levels.
DAY 2: December 2nd, 2022
SESSION: Incorporation of ICH M7 Guidelines
◆ ICH M7 in Early and Late Drug Development.
◆ Impurity Qualification Using (Q)SAR Techniques.
◆ Producing (Q)SAR Assessments in Compliance with ICH M7.
