Hue Kwon, PhD Samsung Bioepis

Dr. Kwon has over 20 years of experience in GxP quality and regulatory strategies from working within the biopharmaceutical industry including being a Vice President and Quality Team Leader at Samsung Bioepis providing GxP quality and compliance oversight for the end-to-end drug development and lifecycle and being the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.

Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.