Back To Schedule
#373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs
Chair
Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including...
Read More →
Speakers
Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality...
Read More →
Therapeutic Area Lead, Clinical Safety and Risk Management, Oncology, and Bone, Merck Research Laboratories
Nina Stuccio, D.O. is the Therapeutic Area Lead, Oncology and Bone, Global Safety and an Industry member of the Clinical Trial Transformation Initiative (CTTI) IND Safety Advancement Project, focused on oncology trials to determine barriers and identify solutions for compliance with...
Read More →
Wednesday June 29, 2016 4:00pm - 5:15pm EDT
113B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA