October 26, 2005


Slides Presented at AC meeting


Alcohol-induced Dose Dumping


(1) Clinical Relevance of Alcohol-induced Dose Dumping


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



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


Lawrence Yu, Ph.D.

Director for Science, Office of Generic Drugs



(2) Office of New Drug Quality Assessment Approach



Chi-Wan Chen, Ph.D.

Deputy Director, ONDQA, OPS, CDER, FDA

(3) Office of Biotechnology Products Approach



Barry Cherney, Ph.D.

Deputy Director, Division of Therapeutic Proteins,

Office of Biotechnology Products, OPS, CDER, FDA


Questions to the Committee




Open Public Hearing Speaker



Girish Malhotra, P. E.

EPCOT International

Development of a Peer Review-based Research Program within OPS



Keith Webber, Ph.D.

Deputy Director, OPS, CDER, FDA

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



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?



Larry Augsburger, Ph.D.

University of Maryland School of Pharmacy

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



Raymond H Scherzer, Ph.D.

Glaxo SmithKline