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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

FDA Forum

Session Chair(s)

John  Weiner, JD

John Weiner, JD

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States

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

Speaker(s)

Peter  Marks, MD, PHD

Panelist

Senior Vice President, Molecule Discovery and Head of Infectious Disease, Eli Lilly and Company, United States

Angela  Krueger

Panelist

Acting Deputy Director, Office of Device Evaluation, CDRH , FDA, United States

Douglas C. Throckmorton, MD

Panelist

Deputy Center Director for Regulatory Programs CDER, FDA, United States

Tamy  Kim, PHARMD

Panelist

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States

Paul  Kluetz, MD

Panelist

Deputy Director, Oncology Center of Excellence, OC, FDA, United States

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