Dr. Monika Chabicovsky is an independent consultant for drug development and regulatory affairs. She trained in experimental cancer research and toxicology at the Medical University of Vienna, the University of Cardiff and the University of Innsbruck. She holds a PhD in cancer research, a master in toxicology and a diploma in regulatory affairs. She is a EUROTOX registered toxicologist, author of several scientific publications in peer-reviewed journals and holds international patents. Previously she was with Austrian and US biotech companies, where she was responsible for regulatory affairs and toxicology. Since 2005 she works with Granzer Regulatory Consulting & Services as a Senior Consultant in Munich. In 2006 she founded MC Toxicology Consulting, with its core business focused on the nonclinical development of biologics, small molecules, vaccines and advanced therapy medicinal products. Dr. Chabicovsky has signed responsible or contributed significantly to drug development programs and Marketing Authorisation Applications of numerous drugs in Europe, USA & Canada.