ADVISORY
COMMITTEE FOR PHARMACEUTICAL SCIENCE
Slides
Presented at AC meeting
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Alcohol-induced Dose Dumping |
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(1) Clinical Relevance of
Alcohol-induced Dose Dumping |
Robert Meyer, MD. Director, Office of Drug Evaluation II, Office of New Drugs (OND), CDER, FDA |
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(2) Mitigating the Risk
Posed by Alcohol-induced Dose Dumping |
Ajaz Hussain, Ph.D. Deputy Director, OPS, CDER, FDA |
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Implementation of Quality-by-Design (QbD) Principles in CMC
Review |
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(1) Office of
Generic Drugs Approach |
Director for Science,
Office of Generic Drugs (OGD), OPS, CDER, FDA |
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(2) Office of New
Drug Quality Assessment Approach |
Chi-Wan Chen, Ph.D. Deputy Director, ONDQA,
OPS, CDER, FDA |
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(3) Office of
Biotechnology Products Approach |
Barry Cherney, Ph.D. Deputy Director, Division of Therapeutic Proteins, Office of Biotechnology Products, OPS, CDER, FDA |
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Questions to
the Committee |
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Open Public
Hearing Speaker |
Girish Malhotra, P. E. EPCOT International |
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Development
of a Peer Review-based Research Program within OPS |
Keith Webber, Ph.D. Deputy Director, OPS, CDER, FDA |
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Corrected IPAC-RS Perspective from |
Michael Golden Glaxo SmithKline (representing IPAC-RS) |
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Awareness Topic: Enhancing the Pharmaceutical Education
System |
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(1) An Academic Perspective - "Is There a Crisis in the
Supply of Qualified Pharmaceutical Scientist Specialists in Product
Development and Related Technologies?” |
Larry Augsburger, Ph.D. University of |
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(2) An Industry Perspective - "The Challenge Ahead: Pharma
Engineering & Technology in the Future" |
Raymond H Scherzer, Ph.D. Glaxo SmithKline |