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Program Code:
431
Date:
Thursday, June 27, 2013
Time:
10:45 AM to 12:15 PM
EST
CHAIR
:
Nancy Smith, PhD, retired from CDER/FDA in 2009 after over 21 years. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and served as a DIA board member of from 2002-2008. She is currently an ORISE Fellow at FDA developing training for new reviewers.
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SPEAKER
(S):
John K Jenkins, MD (SPKAGY), Director, Office of New Drugs, CDER, FDA, United States
Christine M. V. Moore,
PhD (SPKAGY), Acting Director, Office of New Drug Quality Assessment, OPS, CDER,
FDA, United States
Dr. Moore is currently the Acting Director of CDER's Office of New Drug Quality Assessment (ONDQA) where she is at the forefront of development and implementation of agency QbD initiatives. She is a PhD Chemical Engineer with extensive experience in API process development and manufacturing.
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Gerald J. Dal Pan,
MD (SPKAGY), Director, Office of Surveillance and Epidemiology, CDER,
FDA, United States
He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins. He trained in Internal Medicine at the Hospital of the Univ of Pennsylvania, and in Neurology at Johns Hopkins. He is board certified in Internal Medicine and Neurology.
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Robert T. O'Neill,
PhD (SPKAGY), Senior Statistical Advisor, Office of Translational Sciences, CDER,
FDA, United States
Dr. O'Neill is the Director of the Office of Biostatistics (OB) in Office of Translational Sciences in the Center for Drug Evaluation and Research (CDER), Food and Drug Administration. His Office provides biostatistical and scientific computational leadership and support to all programs of CDER.
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Robert J. Temple,
MD (SCHAGY), Deputy Center Director for Clinical Science, CDER,
FDA, United States
Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.
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Justina A. Molzon,
JD,MPharm (SPKAGY), Associate Center Director for International Programs, CDER,
FDA, United States
Justina is a pharmacist and attorney, and a commissioned officer in the U.S Public Health Service. She is currently the Associate Director for International Programs, CDER/USFDA One of her primary responsibilities is coordination of CDER’s efforts related to the ICH.
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Description
This is a roundtable discussion with CDER leadership. Topics to be discussed will depend on the interests of the audience. Panel members will discuss and update regulatory changes and the current hot topics at CDER.
Part 1 of this forum will take place Thursday, June 27 at 9:00 am