Teresa Wegesser
Sr. Principal Scientist
Teresa Wegesser, PhD, is a Scientific Director in Translational Safety & Risk Sciences at Amgen and a recognized subject matter expert in impurity safety assessment, including ICH Q3A/B, M7, Q3C, Q3D, nitrosamines, excipients, and CMC mitigation strategies. External to Amgen, Teresa is also involved in impurity and excipient related roles in PhRMA, EWG ICH Q3D, IQ DruSafe, IPEC Americas, and EFPIA working groups, and has published on impurities and excipient safety. As a Nonclinical Safety Project Team Representative, Teresa provides strategic guidance on cross-functional development teams for both small and large molecules, spanning all phases of development, with expertise in safety liability assessment, nonclinical study design and interpretation, and regulatory submissions.
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.
