ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

October 26, 2005

 

Slides Presented at AC meeting

 

Alcohol-induced Dose Dumping

 

(1) Clinical Relevance of Alcohol-induced Dose Dumping

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Robert Meyer, MD.

Director, Office of Drug Evaluation II,

Office of New Drugs (OND), CDER, FDA

 

(2) Mitigating the Risk Posed by Alcohol-induced Dose Dumping

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Ajaz Hussain, Ph.D.

Deputy Director, OPS, CDER, FDA

Implementation of Quality-by-Design (QbD) Principles in CMC Review

 

(1) Office of Generic Drugs Approach

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Lawrence Yu, Ph.D.

Director for Science, Office of Generic Drugs

(OGD), OPS, CDER, FDA

 

(2) Office of New Drug Quality Assessment Approach

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Chi-Wan Chen, Ph.D.

Deputy Director, ONDQA, OPS, CDER, FDA

(3) Office of Biotechnology Products Approach

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Barry Cherney, Ph.D.

Deputy Director, Division of Therapeutic Proteins,

Office of Biotechnology Products, OPS, CDER, FDA

 

Questions to the Committee

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Open Public Hearing Speaker

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Girish Malhotra, P. E.

EPCOT International

Development of a Peer Review-based Research Program within OPS

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Keith Webber, Ph.D.

Deputy Director, OPS, CDER, FDA

Corrected IPAC-RS Perspective from October 25, 2005 (Revised slide presentation)

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Michael Golden

Glaxo SmithKline (representing IPAC-RS)

 

Awareness Topic: Enhancing the Pharmaceutical Education System

 

(1) An Academic Perspective - "Is There a Crisis in the Supply of Qualified Pharmaceutical Scientist Specialists in Product Development and Related Technologies?

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Larry Augsburger, Ph.D.

University of Maryland School of Pharmacy

(2) An Industry Perspective - "The Challenge Ahead: Pharma Engineering & Technology in the Future"

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Raymond H Scherzer, Ph.D.

Glaxo SmithKline