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Thursday, June 22 • 9:00am - 10:30am
#401: FDA Forum

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Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

The FDA Forum will focus on inter-center collaboration between CDER, CDRH, CBER, and the Office of Combination Products. The recently established Oncology Center of Excellence will be highlighted as a new area of collaboration. FDA representatives will share how they collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.

Learning Objectives

Discuss how the various centers in FDA collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.

Chair

John Barlow Weiner, JD

Speaker

Panelist
Peter W. Marks, MD, PhD

Panelist
Angela C. Krueger

Panelist
Douglas C. Throckmorton, MD

Panelist
Tamy Kim, PharmD

Panelist
Paul Kluetz, MD



Speakers
avatar for Tamy Kim

Tamy Kim

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... Read More →
avatar for Paul Kluetz

Paul Kluetz

Associate Director for Patient Outcomes (Acting), OCE, FDA
Paul G. Kluetz, M.D., is a medical oncologist and the Acting Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. He is interested in defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval a... Read More →
AK

Angela Krueger

Acting Deputy Director, Office of Device Evaluation, CDRH, FDA
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Served as Clinical Director of Hematology at Brigham and Women's Hospital, worked in the pharmaceutical industry on the clinical development of hematology and oncology products, led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He join... Read More →
avatar for Douglas Throckmorton

Douglas Throckmorton

Deputy Director, Regulatory Programs, OCD, CDER, FDA
As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States.
avatar for John Weiner

John Weiner

Associate Director, Policy and Product Classification Officer, OCP, OC, FDA
John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors... Read More →


Thursday June 22, 2017 9:00am - 10:30am
S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics Public Policy,Devices-Combination Products,StudentProgramming
  • Credit Type CME, IACET, RN
  • Tags Forum