8^th Asian Biologics and Biosimilars Congress

Biography

Dr. Iliach, Ph.D. is a Senior Director Global Regulatory Strategy and CMC at the Biosimilar Center of Excellence, QuintilesIMS. She has more than 15 years’ experience in healthcare industry, including the last 10 years in regulatory affairs. Her expertise lies in the development of global regulatory strategy for biosimilars with the focus on overall quality and CMC compliance. She has provided a global regulatory strategy and was involved in CMC development for number of products including biosimilars of Avastin, Herceptin, Humira, MabThera/Rituxan. She has a particular focus and expertise in regulatory and CMC requirements for biosimilars and regularly presents and writes on the topic. She has a PhD in Pharmaceutical Science from St. Petersburg Chemical and Pharmaceutical Academy, Russia. Oxana is also a professor at Seneca College of Applied Arts and Technology, Toronto, Canada and a member of CAPRA (Canadian Association of Professionals in Regulatory Affairs) and RAPS.

Research Interest

Biosimilars and Biologics Product Development, Characterization, Regulatory Intelligence