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A Message from the Co-Chairs of the FDA-Duke Global Regulatory Workshop

Welcome to this workshop!Cancer remains a serious global health threat. Oncology drug development has continued to lead other therapeutic areas in addressing the highly unmet medical needs of the cancer patients and their treatment, attested by ever-increasing numbers of global oncology clinical trials. Therefore, speeding up the development and making drugs available as rapidly as […]

Schedule for FDA-Duke Global Pre-Workshop

FDA-Duke Global Regulatory Pre-Workshop White Flint Amphitheater Date: Tuesday, May 7, 2019 8:00 – 8:30 AM Registration/Continental Breakfast 8:30 – 8:35 am Welcome/Introduction/Goals of the Workshop Speaker Ke Liu US FDA 8:35 – 10:05 am Moderator Richard Pazdur, US FDA Session I: International Regulators’ Forum Agnes Chan Singapore HSA Larissa Higgins EMA Representative Jaigi Mathai Health […]

Schedule for AAADV Pre-Workshop for Patient Advocates

Agenda AAADV Pre-Workshop for Patient Advocates Location: Salon H Date: Tuesday, May 7, 2019Time: 12:30 PM-5:00 PM 11:45 AM-12:30 PM Registration 12:30 PM-1:00 PM Introduction/ Challenges and Questions for the Day Speakers H Kim Lyerly, MD DAAD Director and Duke University Mary (Dicey) Jackson Scroggins M.A.  (International Gynecologic Cancer Society) Virginia Kwitkowski, MS, ACNP-BC FDA, Div. of […]