Dr. Tobias Schümmer, ERT
Senior Toxicologist
Tobias Schümmer is a biochemist and toxicologist with more than 10 years of experience in the pharmaceutical industry. After a Ph.D. in physical biochemistry from the Technische Universität München, he stayed as a Post-Doc at the Alberta RNA Research and Training Institute in Canada. Tobias started working in the field of early pharmaceutical development at a generics and medical device company. In parallel, he obtained a degree in toxicology and environmental protection from Universität Leipzig. Since October 2022, Tobias is a toxicologist at Fresenius Kabi where he is working in the field of impurities with special focus on nitrosamines.
DAY 2: December 2nd, 2026
SESSION: Nitrosamine Sources Beyond the API: The Role of Container Closure Systems
◆ Regulatory background for the requirement of nitrosamine risk assessments for nitrosamines originating from container closure systems.
◆ Differentiation between nitrosamines formed in the raw material and formed during the shelf-life of the drug product (short excursion to Jost et al. (2026)).
◆ Identification of nitrosamines at risk.
◆ General considerations on nitrosamine risk assessments.
