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FOOD AND DRUG ADMINISTRATION - page 17 / 263

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DR. DeLUCA:  Pat DeLuca, University of Kentucky.

DR. SHARGEL:  Leon Shargel, Eon Labs, Inc.

DR. SHEK:  Efraim Shek, Abbott Laboratories.

DR. HAUCK:  Walter Hauck.  I'm Professor and Head of Biostatistics at Thomas Jefferson University.

DR. KIBBE:  Thank you, and I'm Art Kibbe, and I work at Wilkes University, Chairman of the Pharmaceutical Sciences Department and acting Chair of this committee.

Our first speaker will be the acting Chair of the Division, Helen Winkle, who's been acting for three years.

MS. WINKLE:  Good morning, everyone.

I'm going to talk just briefly this morning about the GMP initiative for the 21st Century.  As I said yesterday, I think that it's important for the committee to have an idea about this initiative because it is such an important part of what we're doing in the center.  I want to start off by saying that although the title of it has been in the press and when we started this initiative back in August of 2002, it was titled the Pharmaceutical

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