Associate Director of Regulatory Affairs, OCE
Tamy Kim is Associate Director, Regulatory Affairs (ADRA), OHOP/OCE, FDA. She has spent over 13 years at the FDA, first as a Regulatory Project Manager in the Division of Neurology Products and then as the ADRA for OHOP and OCE. Her responsibilities include developing and implementing policy, procedures and structure of the OCE related to review processes, including Real Time Oncology Review (RTOR), Project Facilitate, Medical Oncology Review and Evaluation (MORE) team reviews, breakthrough therapies, expedited reviews and safety.
Previous to her FDA experience, Tamy worked in medical affairs in a pharmaceutical company and completed a drug information residency at Purdue University
Monday, September 23
2:05 PM – 3:00 PM
Tuesday, September 24
4:00 PM – 5:30 PM