Unmasking Pharma Impurities: Navigating Challenges with USP Perspective

Christian is Senior Manager in the Scientific Affairs Group for the EMEA region, with a focus on Small Molecules, USP’s General Chapters and Biologics. He collaborates with scientific experts and stakeholders and is responsible to protect and grow USP’s scientific reputation in the region and globally. Before joining USP, Christian worked for seventeen years in the field of pharmaceutical reference standards with a focus on impurities, and before that in the IVD (In Vitro Diagnostic) industry. His scientific expertise includes impurity testing, reference standards characterization and adjacent fields. Christian has published several articles and white papers on topics such as impurities, overview about (certified) reference materials, and the use of reference standards in method development and validation.

Ulrich leads a global team supporting regulatory compliance for manufacturing active and biologic drug substances, including site registrations worldwide. With over 25 years of experience in regulatory and quality roles, he holds a PhD in Medicinal Chemistry and a Master in Drug Regulatory Affairs. Ulrich chairs the IPEC Europe Nitrosamine Task Force, participates in ICH and European Pharmacopoeia expert groups, and serves on the pharmacopoeia committee on medicinal chemistry at BfArM.