Antioxidants, a safe and viable Inhibition Strategy for Nitrosamine Formation In Drug Products – The webinar
Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products, as well as for new drug applications.
There will be three experts on nitrosamines mitigation in our webinar together with DSM.
Do you have a question for the experts? Just send it to [email protected] . We will ask them during the Questions & Answers panel discussion in the webinar.
Short introduction of the three experts:
Malcolm Ross, President @Generapharm-Training and Consultancy
Dr. Ross has a pharmacy degree from the University of London, is a qualified pharmacist and has a Ph.D in medicinal Chemistry. He was lecturer in the Welsh School of Pharmacy and a visiting lecturer in the Department of Chemistry at Bar Ilan University. With over 35 years experience in the Pharmaceutical industry, the last 15 at corporate level, Dr. Ross has been intimately involved in strategy planning and analysis, pipeline management, business development, quality issues and related activities. Technically he specialized in the development of drug substance and drug products in both the analytical and formulation areas and has been responsible for establishing R&D in several companies in different international environments. Experience ranges from small CRO style to large corporate structures with multilevel reporting.
Kausik K. Nanda, Pharmaceutical Scientist @Merck
Accomplished scientist with broad experience in the fields of drug development (analytical and drug degradation chemistry) and drug discovery (medicinal chemistry). Leader in solving problems arising from chemical interaction in the early through late stage of drug development. Expert in Medicinal chemistry, Nitrosamine chemistry, nitrosamine risk assessment in drug products and drug substances, inhibition of nitrosamine formation in drug products. Experienced in dealing with regulatory requirements in the area of degradation products and mutagenic impurities in drug product.
René Stemmler, Senior Scientist II, Process Chemistry R&D @DSM
René Stemmler is an experienced process chemist with significant expertise in molecular modeling, cheminformatics and data science. He began his studies in chemistry at the University of Freiburg, Germany and the University of North Carolina at Chapel Hill, US where he received his diploma in 2003. He completed his PhD in organic chemistry and asymmetric catalysis from RWTH Aachen University, Germany in 2007 and his postdoctorate at Stanford University in the US with Paul Wender on transition metal catalyzed cycloadditions. René Stemmler started as Laboratory Head in Process Chemistry R&D at DSM in 2009 and is now Senior Scientist II.