#412: CDER Town Hall
Chair
Adjunct Professor, Temple University, FDA Alumni
Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA...
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Speakers
Associate Director for Therapeutic Biologics, TBBT, OND, CDER, FDA
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar...
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Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
Director, Office of Pharmaceutical Quality, CDER, FDA, United States
With more than 25 years of pharmaceutical industry experience, Dr. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Before joining FDA, Dr. Kopcha served as vice president...
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Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations...
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Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology...
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Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological...
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Thursday June 30, 2016 10:45am - 12:00pm EDT
114
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA