A Drug Quality System for the 21St Century April 22-24, 2003 Listing of Attendees
A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Abboud, Leila Armstrong, Ronald Blumberg, Eric Washington, DC Boehringer Ingelheim Pharm Food and Drug Administration Ridgefield, CT Rockville, MD Abrams, Shelley Eli Lilly and Company Bailey, John Blumenschein, Frederick Indianapolis, IN CTFA Food and Drug Administration Washington, DC Rockville, MD Agarwal, Rajiv Food and Drug Administration Bangert, Fred Blumenstein, Jeffrey Rockville, MD Synthon Pharmaceutials Pfizer, Inc. Chapel Hill, NC Groton, CT Agharkar, Shreeram Aventis Pharmaceuticals Co. Barreto, Dan Boehm, Garth Bridgewater, NJ Janssen Pharmaceutica Alpharma Beerse, Belgium Elizabeth, NJ Aikman, Mark Osmotica USA Barrett, Jennifer Boos, Lawrence Wilmington, NC Barr Laboratories President & CEO Pomona, NY Fort Worth, TX Ajac, Akin-Remi Ivax Pharmaceuticals, Inc. Batliner, Stephanie Bowen, Keith Miami, FL Phoenix Scientific, Inc. Centocor, Inc. Saint Joseph, MO Malvern, PA Akintonde, Daniel Hoffmann-La Roche, Inc. Baum, Robert Bowers, Lee Nutley, NJ Pfizer, Inc. Food and Drug Administration Groton, CT Baltimore, MD Alasandro, Mark Merck & Co., Inc. Beckerman, Peter Boyko, Jean West Point, PA Food and Drug Administration Purdue Pharma, LP Rockville, MD Ardsley, NY Alexander, Diane Food and Drug Administration Beels, Christopher Brame, Will Rockville, MD GlaxoSmithKline Aventis Pasteur Stevenage, United Kingdom Marcy l'Etoile, France Allen, Jay Stelex-TVG Beltran, Philippe Brochu, William Bensalem, PA Sanofi-Synthelabo Mylan Technologies, Inc. Malvern, PA St Albans, VT Allen, Susan Food and Drug Administration Bensley, Dennis Brock, Chris Rockville, MD Food and Drug Administration PPD Rockville, MD Wilmington, NC Allera, Edward John Buchanan Ingersoll Benson, Sheri Buehler, Gary Washington, DC Monsanto Food and Drug Administration Saint Louis, MO Rockville, MD Angelo, Michael Merck & Co., Inc. Berg, Mats Buhay, Nicholas Whitehouse Station, NJ Ernst & Young Food and Drug Administration Malmoe, Sweden Rockville, MD Anisko, Joseph Alkermes, Inc. Berger, Mitchell Bunpei, Matoba Cambridge, MA Thompson Publishing Group IBM Business Consulting Svcs Washington, DC Tokyo, Japan Anliker, Sally Eli Lilly and Company Berglund, Richard Burgenson, Al Indianapolis, IN Eli Lilly and Company Cambrex Bio Science Indianapolis, IN Walkersville, MD Anquez, Christelle Food and Drug Administration Bergt, Gregory Burlington, Bruce Rockville, MD Pennfield Animal Health Wyeth Pharmaceuticals Omaha, NE St. Davids, PA Arakangas, John Aramark AB Bird, Bruce Burtis, Mary Taylor Mariefred, Sweden Pfizer, Inc. Wyeth New York, NY Andover, MA
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Page 1 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Butler, Roger Chin, Tom DalPan, Gerald Eli Lilly Food and Drug Administration Food and Drug Administration Greenfield, IN Rockville, MD Rockville, MD
Byers, James Chiu, Yuan-yuan Danford, Christopher Eli Lilly Food and Drug Administration Alcon Laboratories, Inc. Indianapolis, IN Rockville, MD Fort Worth, TX
Byrn, Stephen Christian, Jorge Dansereau, France Purdue University Food and Drug Administration Health Canada Lafayette, IN Rockville, MD Ottawa, ON Canada
Cannon, Laura Chudasama, Mahesh Dave, Pankaj Barr Laboratories, Inc. TEVA Pharmaceuticals USA Geneva Pharmaceuticals Cincinnati, OH Fairfield, PA Dayton, NJ
Cantor, Jennifer Clark, Jon Davis, Colin 3M Pharmaceuticals Food and Drug Administration Pfizer, Inc. Saint Paul, MN Rockville, MD Kalamazoo, MI
Caphart, Monica Claycamp, Gregg Dayman-Rutkus, Kim Food and Drug Administration Food and Drug Administration Health Canada Rockville, MD Rockville, MD Ottawa, ON Canada
Carr, Paul Cobbs, Lindsay De, Swapan Shotwell and Carr, Inc. Food and Drug Administration Food and Drug Administration Flower Mound, TX Rockville, MD Rockville, MD
Carroll, Michael Cohen, James DeMarco, Robert Hoffmann LaRoche Inc. Food and Drug Administration Wyeth BioPharma Nutley, NJ Rockville, MD Andover, MA
Casey, Dennis Colborn, Alan DeVecchi, Franco Pfizer, Inc. GlaxoSmithKline VPCI, Inc. Groton, CT Zebulon, NC West Bloomfield, MI
Chan, Tony Cole, Elaine DeWitt, Janet Guidant Corporation Food and Drug Administration Abbott Labs Temecula, CA Rockville, MD North Chicago, IL
Chan, Yeung Collinsworth, Norma Diaz, Raul Bristol-Myers Squibb Co. GlaxoSmithKline Merck & Co., Inc. New Brunswick, NJ Durham, NC West Point, PA
Chang, Karen Concavage, Debby Dietrick, John Alza Corporation AstraZeneca Pharmaceuticals LP Food and Drug Administration Mountain View, CA Westborough, MA Rockville, MD
Charity, Anthony Cook, Jonathan Doleski, David Food and Drug Administration Food and Drug Administration Food and Drug Administration Rockville, MD Rockville, MD Rockville, MD
Chen, Xiao-Hong Cooney, Peter Dove, Andrew Food and Drug Administration Food and Drug Administration The Pink Sheet Rockville, MD Rockville, MD Chevy Chase, MD
Chermak, Todd Cordts, Jerome Doyle, Kevin Abbott Laboratories Food and Drug Administration Centocor Abbott Park, IL Rockville, MD Malvern, PA
Chesney, David Crandell, Adela Drumm, Patrick KMI/PAREXEL ORGANICS/LaGrange, Inc. Novartis Pharmaceuticals Waltham, MA Northbrook, IL East Hanover, NJ
Chiapperino, Dominic Crispin, Thomas D'sa, Albinus Food and Drug Administration Bayer AG Healthcare Group Food and Drug Administration Rockville, MD Leverkusen, Germany Rockville, MD
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Page 2 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Duffy, Eric Ferguson, Shirnette George, Mathew Food and Drug Administration Food and Drug Administration Pfizer, Inc. Rockville, MD Rockville, MD Brooklyn, NY
Duple, Linda Finkbohner, John Ghani, Sultan Bimeda, Inc. Food and Drug Administration Health Canada Lehigh, IA Rockville, MD Ottawa, ON Canada
Ealer, Norbert Fischer, Gerd Giertych, Amy AstraZeneca Pharmaceuticals Aventis Pharma Baxter Healthcare Corp. Wilmington, DE Frankfurt, Germany Round Lake, IL
Edge Azuara, Kathy Folestad, Staffan Gilbert, Alicia Baxter Healthcare Corp. Astrazeneca Pharmaceuticals Human Genome Sciences, Inc. Westlake Village, CA Molndal, Sweden Rockville, MD
Egan, William Foster, Todd Giorgetti, Michael Food and Drug Administration Pfizer, Inc. Alkermes Rockville, MD Kalamazoo, MI Cambridge, MA
Ellsworth, Douglas Franklin, Craig Goldsmith, John Food and Drug Administration Salmedix Food and Drug Administration Parsippany, NJ San Diego, CA Rockville, MD
Erario, Al Frederiksen, Linda Gomez, Ralph Dey, L.P. H. Lundbeck A/S Hoffmann-La Roche, Inc. Napa, CA Valby, Denmark Nutley, NJ
Erlich, Ronald Friedman, Richard Good, Nancy JJPRD, LLC Food and Drug Administration Aventis Behring Raritan, NJ Rockville, MD King of Prussia, PA
Evans O'Connor, Linda Fry, Edmund Gore, Ashok IVAX Pharmaceuticals Ivax Corporation Spectrum Pharmaceuticals Northvale, NJ Miami, FL Irvine, CA
Eyraud, John Gaddy, Herschel Graeff, Brian Eastern Research Group, Inc. Herschel J. Gaddy & Associates AstraZeneca Lexington, MA Saint Joseph, MO Westborough, MA
Fabian, Arthur Ganey, Michael Gray, Stephanie SST Corporation Pfizer, Inc. GlaxoSmithKline Clifton, NJ Groton, CT Research Triangle Park, NC
Fahmy, Raafat Gantt, Sylvia Grazal, John Food and Drug Administration PQRI AstraZeneca Pharmaceuticals Rockville, MD Arlington, VA Wilmington, DE
Fain, Kevin Gardine, Thomas Gregory, Norman Food and Drug Administration Food and Drug Administration Food and Drug Administration Rockville, MD Philadelphia, PA Rockville, MD
Falk, Arthur Gavini, Muralidhara Grieve, Steven Elan Pharmaceutical Mgmt. Food and Drug Administration Pfizer, Inc. Morristown, NJ Rockville, MD Kalamazoo, MI
Famulare, Joseph Gedz, Taras Grooms, Paul Food and Drug Administration Health Canada Baxter Healthcare Corporation Rockville, MD Ottawa, ON Canada Round Lake, IL
Famulare, Joseph Gelwicks, Jeffrey Gross, Michael Food and Drug Administration Eli Lilly and Company Aventis Behring Rockville, MD Indianapolis, IN King of Prussia, PA
Fazzari, Frank George, J. Glenn Guazzaroni, Maria Phoenix Regulatory Associates QRC Associates, LLC Pfizer, Inc. Sterling, VA Bedminster, NJ Morris Plains, NJ
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Page 3 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Guinty, William Hawley, Leslie Horowitz, David Aventis Pfizer, Inc. Food and Drug Administration Bridgewater, NJ Kalamazoo, MI Rockville, MD
Guito, Kenneth Hayes, Denise Howe, Greg Aventis Pasteur, Inc. Pfizer, Inc. Schering Plough Animal Health Swiftwater, PA New York, NY Union, NJ
Gulbinski, Donna Hayes, Mark Hsieh, Li-Shan Merck & Co., Inc. Genzyme Corporation Food and Drug Administration West Point, PA Framingham, MA Rockville, MD
Gump, Edwin Heleter, Chris Hughes, Martin Boehringer Ingelheim Pharm Wyeth BioPharma Fort Dodge Animal Health Ridgefield, CT Andover, MA Princeton, NJ
Gupta, Patti Henrikson, Erik Hussain, Ajaz Genentech Food and Drug Administration Food and Drug Administration S San Francisco, CA Rockville, MD Rockville, MD
Guyer, C. Greg Henry, Louise Huynh, Mai Merck & Co., Inc. Vertex Pharmaceuticals Food and Drug Administration West Point, PA Cambridge, MA Rockville, MD
Guyer, C. Greg Hentschel, Norbert Incorvia, Gary Merck & Co., Inc. Boehringer-Ingelheim Monsanto West Point, PA Biberach/Riss, Germany Saint Louis, MO
Haberkorn, Richard Hess, Maureen Irminger, Lowell Genzyme Corporation Food and Drug Administration RegConsult Framingham, MA Rockville, MD Ashburn, VA
Hacker, Michael Heymans, Christian Israel, Sean Merck & Co., Inc. Janssen Pharmaceutica NV Teva Pharm. USA Whitehouse Station, NJ Beerse, Belgium North Wales, PA
Hackett, Lisa Hill, Rick Jadeja, Janak DSM Pharmaceuticals Pennfield Animal Health Alpharma USPD Greenville, NC Omaha, NE Elizabeth, NJ
Hager, Steven Hirshfield, Karen Jagota, Nirdosh Gala Biotech Food and Drug Administration Wyeth Middleton, WI Rockville, MD Collegeville, PA
Haggerty, Robert Hobbs, Jack Jani, Rajni Acusphere, Inc. Pfizer, Inc. Alcon Research, Ltd. Watertown, MA New York, NY Fort Worth, TX
Hankinson, Edward Hoffer, John Jankowski, Stan Johnson & Johnson PRD BOC Bimeda, Inc. Beerse, Belgium New Providence, NJ Irwindale, CA
Harapanhalli, Ravi Hoiberg, Charles Janssen, Dan Food and Drug Administration Food and Drug Administration 3M Rockville, MD Rockville, MD Saint Paul, MN
Harris, Gregg Holmes, Elizabeth Janulis, Joan Alcon Laboratories, Inc. GlaxoSmithKline Alpharma USPD Fort Worth, TX Research Triangle Park, NC Elizabeth, NJ
Haseman, Cathrine Holocombe, Frank Jee, Josephine H. Lundbeck A/S Food and Drug Administration Food and Drug Administration Valby, Denmark Rockville, MD Rockville, MD
Hasselbalch, Brian Hooper, Andy Jeffreys, Harry Food and Drug Administration Aventis Amersham Health Rockville, MD Kansas City, MO Princeton, NJ
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Page 4 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Jimenez, Ricardo Kaufman, Zena Koller, Neal Grupo Roche Syntex de Mexico Pfizer, Inc. PDA Toluca, Mexico Skokie, IL Bethesda, MD
Johnson, Anne Kearns, Daniel Kosmoski, Paulette Food and Drug Administration Food and Drug Administration Reliant Pharmaceuticals Philadelphia, PA Rockville, MD Liberty Corner, NJ
Johnson, Richard Kelly, Ernest Kramer, Linda Abbott Laboratories Bio-Technology General Corp. Centocor Abbott Park, IL East Brunswick, NJ Malvern, PA
Joneckis, Christopher Kemmer, Richard Krause, Klaus Food and Drug Administration Bayer Corporation Amgen, Inc. Rockville, MD Berkeley, CA Thousand Oaks, CA
Jones, Betty Kentrup, William Kunz, Philip Food and Drug Administration Aventis Pharmaceuticals Celltech Manufacturing, Inc. Rockville, MD Kansas City, MO Rochester, NY
Jones, Carole Keresty, Georgia Labadt, Majda Food and Drug Administration Bristol-Myers Squibb Hikma Farmaceutica Rockville, MD New Brunswick, NJ Sintra, Portugal
Jones, Harold Kiang, San Lam, See-Yan Air Liquide America Bristol-Myers Squibb Co. Food and Drug Administration Houston, TX New Brunswick, NJ Rockville, MD
Jordan, Kathleen Kientzler, Donald Lambridis, Phyllis Food and Drug Administration Bristol-Myers Squibb Co. Halsey Drug Company, Inc. Rockville, MD New Brunswick, NJ Congers, NY
Kaiser, Cheryl Kim, Byeoung Landa, Michael Food and Drug Administration Tanox, Inc. Food and Drug Administration Rockville, MD Houston, TX Rockville, MD
Kamat, Ganadhish Kim, Chong Ho Landy, John Ranbaxy Food and Drug Administration Aventis Gloversville, NY Rockville, MD Bridgewater, NJ
Kaminski, Edward Kincaid, Janeen Lane, Steve Wyeth Pharmaceuticals Pfizer, Inc. USP St. Davids, PA Morris Plains, NJ Rockville, MD
Kaplan, Richard King, Robert Lang, Paul Cephalon Food and Drug Administration Boehringer Ingelheim West Chester, PA Rockville, MD Ridgefield, CT
Karjian, Lucine Kirkendall, Richard Langille, Stephen Schering-Plough Research Inst. Cardinal Health Food and Drug Administration Kenilworth, NJ Dublin, OH Rockville, MD
Karlton, Peter Kitazawa, Yoshio LaScala, Jon Gilead Sciences JPMA Quintiles, Inc. San Mateo, CA Tokyo, Japan Morrisville, NC
Kasliwal, Ravindra Kobayashi, Norman Lassman, Prescott Food and Drug Administration Pfizer Global R&D PhRMA Rockville, MD La Jolla, CA Washington, DC
Kataria, Annali Koch, Mel Lavin, Kenneth Conformia, Inc. CPAC Teva Pharm. USA Redwood City, CA Seattle, WA North Wales, PA
Kaufer, Michael Kolar, Kevin Layloff, Thomas American Society for Quality Mylan Pharmaceuticals, Inc. Management Sciences for Health Lancaster, PA Morgantown, WV Granite City, IL
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Page 5 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Leadbetter, Mary Lowry, Peter Marnane, William Food and Drug Administration The Immune Response Corp. Food and Drug Administration Rockville, MD King of Prussia, PA Rockville, MD
LeBlanc, Shaun Lu, Allan Maroney-Benassi, Patricia Wyeth BioPharma Pfizer, Inc. Food and Drug Administration Andover, MA New York, NY Rockville, MD
Lefler, Patricia Lyapustina, Svetlana Marten, Tim Food and Drug Administration Garner Carton & Douglas AstraZeneca Pharmaceuticals Rockville, MD Washington, DC Cheshire, United Kingdom
Leinbach, Patricia Lyda, Mary Maselli, Nick Scientific Consulting of VA KMI Consulting Services Barr Laboratories, Inc. Winchester, VA Arlesheim, Switzerland Pomona, NY
Leiper, Kenneth Lydersen, Bjorn Masiello, Steven Benson Associates The Immune Response Corp. Food and Drug Administration Grantham, United Kingdom King of Prussia, PA Rockville, MD
Lennon, Clark Lynch, Mark Massa, Tobias Pfizer, Inc. KMI/Parexel LLC Eli Lilly and Company New York, NY Rockville, MD Indianapolis, IN
Lerner, David MacDonald, Marcy Mastronardy, Linda Rusco, Inc. Apotex Corp. Andrx Pharm., Inc. Plymouth Meeting, PA Vernon Hills, IL Fort Lauderdale, FL
Letvenuk, Linda Machado, Stella Mathews, Mary Jane Bimeda-MTC Food and Drug Administration Food and Drug Administration Cambridge, ON Canada Rockville, MD Rockville, MD
Lewis, Jocelyn Macher, Jeffrey Matoba, Bunpei Food and Drug Administration Georgetown University IBM BCS Japan Rockville, MD Washington, DC Tokyo, Japan
Little, Jacqueline Madsen, Russell Maturu, Pramoda Food and Drug Administration PDA Food and Drug Administration Rockville, MD Bethesda, MD Rockville, MD
Little, Laureen Majeti, Nagesh May, Stacey i2i Corporation Ranbaxy AAPS Idyllwild, CA Gloversville, NY Arlington, VA
Lloyd, Ramona Major, Marsha McEvoy, Kate Bristol Myers Squibb Co. Johnson & Johnson Food and Drug Administration Pennington, NJ Hershey, PA Rockville, MD
Lockyer, George Malaviya, Arun McFarland, David Eisai, Inc. Bimeda-MTC Dickinson's FDA Review Durham, NC Cambridge, ON Canada Camp Hill, PA
Lohan, Gerard Manco, Nate McKee, Roberta Merck Research Laboratories Fort Dodge Animal Health Merck & Co., Inc. West Point, PA Princeton, NJ West Point, PA
Long, Kerry Mann, Peter McKenney, John Pfizer, Inc. Centocor, Inc. SEC Associates, Inc. Skokie, IL Malvern, PA Morrisville, NC
Lorefice, George Markus, John Mehringer, Nikki Bristol-Myers Squibb Co. AAC Consulting Group, Inc. Eli Lilly & Company Syracuse, NY Rockville, MD Indianapolis, IN
Love, Richard Marlarkey, Mary Melendez, Edwin Connetics Corporation Food and Drug Administration Food and Drug Administration Palo Alto, CA Rockville, MD Rockville, MD
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Page 6 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Merdian, Stuart Moskowitz, Ellen Neely, Brian Aventis Pharma Intervet, Inc. Don Hill and Associates Kansas City, MO Flemington, NJ Greenwood, IN
Merritt, Babette Mudan, Jasmail Neves, Caristina Food and Drug Administration Hoffmann LaRoche, Inc. Hikma Farmaceutica Rockville, MD Nutley, NJ Sintra, Portugal
Metcalfe, John Mulchi, Mike Nickerson, Jackson Food and Drug Administration Eisai, Inc. Washington University Rockville, MD Research Triangle Park, NC Saint Louis, MO
Meyer, Mary Mullaney, June Niedelman, Steven Food and Drug Administration GlaxoSmithKline Food and Drug Administration Rockville, MD Research Triangle Park, NC Rockville, MD
Migliaccio, Gerry Mullin, Theresa Nishimura, Masayuki Pfizer, Inc. Food and Drug Administration Shimadzu Corporation New York, NY Rockville, MD Columbia, MD
Miller, Ronald Mundkur, Christine Nishitani, Shinji Bristol-Myers Squibb, Co. Barr Laboratories, Inc. Otsuka America Pharmaceutical New Brunswick, NJ Pomona, NY Rockville, MD
Miner, David Munro, Gordon Norris, Ana Eli Lilly and Company Medicines Control Agency (MCA) Food and Drug Administration Indianapolis, IN London, England Rockville, MD
Miracco, Kathy Murphy, Elise Ogram, Lana Food and Drug Administration Food and Drug Administration Food and Drug Administration Rockville, MD Rockville, MD Rockville, MD
Mire-Sluis, Anthony Murphy, Robert Okafo, Ngozi Food and Drug Administration Allergan, Inc. ALZA Corporation Rockville, MD Irvine, CA Mountain View, CA
Mischler, Philip Murtagh, Marie O'Leary, Niall Quintiles, Inc. Eisai Medical Research, Inc. Alkermes, Inc. Kansas City, MO Teaneck, NJ Winchester, MA
Mitchell, Ed Nagao, Lee Oliynyk, Nicole Aventis Pharmaceuticals Garner Carton & Douglas Genzyme Corporation Kansas City, MO Washington, DC Framingham, MA
Mitchell, Stephen Nair, Stefanie Olsen, Bernard Norbrook Laboratories Limited Hoffmann-La Roche, Inc. Eli Lilly and Company Newry, United Kingdom Nutley, NJ Lafayette, IN
Mitra, Amit Nakano, Kenichi Olson, Margit Food and Drug Administration Yamatake Corporation Merck & Co., Inc. Rockville, MD Yokohama, Japan West Point, PA
Molzon, Justina Naperstkow, Arvin Ornellas, Timothy Food and Drug Administration Health Canada Amgen, Inc. Rockville, MD Ottawa, ON Canada Longmont, CO
Montemurro, Ann Marie Napolitano, Ralph Overholser, Gloria Food and Drug Administration Hoffmann LaRoche, Inc. Food and Drug Administration Voorhees, NJ Nutley, NJ Rockville, MD
Morfin, Julia Nash, Una Owings, Michael Grupo Roche Syntex de Mexico Boehringer Ingelheim Phase Forward Toluca, Mexico Ridgefield, CT Waltham, MA
Morris, Walt Nasr, Moheb Panagiotis, Scott The Pink Sheet Food and Drug Administration Pennfield Animal Health Chevy Chase, MD Saint Louis, MO Omaha, NE
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Page 7 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Pannunzio, Christine Porter, Edward Ridge, David Human Genome Sciences, Inc. Tyco Healthcare Mallinckrodt Hoffmann-LaRoche, Inc. Rockville, MD Saint Louis, MO Nutley, NJ
Paradeiser, Bernhard Poska, Richard Riggin, Ralph Aventis Pharma GmbH Abbott Labs Eli Lilly and Company Frankfurt, Germany Abbott Park, IL Indianapolis, IN
Parsley, Gloria Poudrier, Richard Riley, Christopher Bayer Healthcare, LLC VetoQuinol ALZA Corporation Shawnee Mission, KS Princeville, QC Canada Mountain View, CA
Patel, Bhupen Poulton, Robert Rivera, Edwin Ohm Laboratories, Inc. Wyeth Pharmaceuticals Food and Drug Administration New Brunswick, NJ King of Prussia, PA Rockville, MD
Patel, Hasmukh Preston, M. Sue Robert, Jean-Louis Food and Drug Administration Chiron Corporation Laboratois National de Sante Rockville, MD Emeryville, CA Luxembourg, Luxembourg
Patterson, Joseph Provin, Herman Roberts, Darryl West Point Pharm. Consulting Fort Dodge Animal Health Johnson & Johnson West Point, PA Fort Dodge, IA Titusville, NJ
Pawar, Vinayak Pulham, David Roberts, James Food and Drug Administration Siegfried Ltd. Boehringer Ingelheim Rockville, MD Zofingen, Switzerland Ridgefield, CT
Pelliccione, Nicholas Purvis-Wynn, Sherry Roberts, Khyati Schering-Plough Research Inst. Food and Drug Administration Food and Drug Administration Kenilworth, NJ Rockville, MD Rockville, MD
Peri, Prasad Radebaugh, Galen Robinson, Willie Food and Drug Administration Schering-Plough Research Inst. MedPointe Pharmaceuticals Rockville, MD Kenilworth, NJ Somerset, NJ
Perrella, Nancy Raju, G K Rocca, Lorenzo Schering Plough Pharmaceutical Newton, MA Food and Drug Administration Springfield, NJ Rockville, MD Ramsbotham, Joyce Peteritas, Gary Solvay Pharmaceuticals Rockel, Cynthia Aventis Pharmaceuticals Weesp, Netherlands Millipore Corporation Kansas City, MO Bedford, MA Razzaghi, Frederick Peterson, Donna CHPA Rodriguez, Alma Amgen, Inc. Washington, DC Pfizer, Inc. Washington, DC San Juan, PR Regan, Peter Pham, Mai Genzyme Corporation Rodriguez, Rebeca Medarex Framingham, MA Food and Drug Administration Annandale, NJ San Juan, PR Remick, Lori Phillips, Joseph Food and Drug Administration Rolli, Nancy ISPE Rockville, MD Food and Drug Administration Blackwood, NJ North Brunswick, NJ Reynolds, Scott Plating, Stephen Merck & Co., Inc. Rothman, Barry GlaxoSmithKline West Point, PA Food and Drug Administration Research Triangle Park, NC Rockville, MD Rhoades, Robert Poliakoff, Nora The Weinberg Group Rudy, Bruce Sanofi-Synthelabo, Inc. Washington, DC Aventis Behring New York, NY King of Prussia, PA Richardson, Anita Poochikian, Guirag Food and Drug Administration Sabourin, Josanne Food and Drug Administration Rockville, MD Alza Corporation Rockville, MD Mountain View, CA
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Page 8 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Saffee, Richard Shah, Dhiren Smith, Peter Pfizer, Inc. Aventis Pharmaceuticals KMI/PAREXEL Holland, MI Kansas City, MO Rockville, MD
Sager, Nancy Shah, Vibhakar Smith, Rick Food and Drug Administration Food and Drug Administration Aventis Pasteur, Inc. Rockville, MD Rockville, MD Swiftwater, PA
Salemme, Jean Shah, Vinod Snider, Bob Food and Drug Administration Food and Drug Administration Eli Lilly and Company Rockville, MD Rockville, MD Indianapolis, IN
Sami, Tamra Showalter, Janet Spencer, Thomas Validation Times Food and Drug Administration Mylan Technologies, Inc. Leesburg, VA Rockville, MD Saint Albans, VT
Sarke, Haripada Shubart, Richard Srinivasan, Viswanathan Food and Drug Administration Pfizer, Inc. Sovereign Pharmaceuticals, LTD Rockville, MD Skokie, IL Fort Worth, TX
Schaeren, Martin Sigild, Dorte Staecker, Daniela ZLB Bioplasma AG H. Lundbeck A/S Boehringer Ingelheim GmbH Bern, Switzerland Valby, Denmark Ingelheim, Germany
Schill, Richard Simmons, John Staehler, David GlaxoSmithKline Food and Drug Administration Eli Lilly and Company Research Triangle Park, NC Rockville, MD Indianapolis, IN
Schladetzky, Kurt Simmons, Steve Stahlhofen, Manfred Eli Lilly and Company Aventis Pharmaceuticals Aventis Pharma Lafayette, IN Kansas City, MO Frankfurt, Germany
Schmuff, Norman Singpurwalla, Nozer Staley, Todd Food and Drug Administration George Washington University Monsanto Co Baltimore, MD Washington, DC Saint Louis, MO
Schou Sorensen, Henrik Sishta, Chand Staples, Carolyn H. Lundbeck A/S Bristol-Myers Sqibb Co. Food and Drug Administration Valby, Denmark New Brunswick, NJ Rockville, MD
Seamon, Kenneth Skeens, Lisa Stavloe, Joann Amgen, Inc. Baxter Healthcare Corp. Alpharma USPD Seattle, WA Waukegan, IL Elizabeth, NJ
Seaver, Sally Skolfield, William Steele, Mark Seaver Associates P&G Pharmaceuticals Pfizer, Animal Health Concord, MA Mason, OH Kalamazoo, MI
Seevers, Robert Slutsky, Bernice Stellon, Ronald Eli Lilly and Company PhRMA AstraZeneca Indianapolis, IN Washington, DC Newark, DE
Sehgal, Sanjay Smedley, Michael Stinavage, Paul Procter & Gamble Pharma, Inc. Food and Drug Administration Food and Drug Administration Mason, OH Rockville, MD Rockville, MD
Sertkaya, Aylin Smith, Alexa Strumph, Peter Eastern Research Group, Inc. Colorcon CV Therapeutics Lexington, MA West Point, PA Palo Alto, CA
Setescak, Linda Smith, Chuck Stull, Rodman Aventis Pharmaceuticals, Inc. Tyco Healthcare Mallinckrodt AstraZeneca Bridgewater, NJ Saint Louis, MO Newark, DE
Setterberg, Susan Smith, George Summers, Jim Food and Drug Administration Food and Drug Administration Dey, L.P. Philadelphia, PA Rockville, MD Napa, CA
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Page 9 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Sundaram, Ram Vanhaecke, Erwin Williams, Roger Millennium Pharmaceuticals Alcon Laboratories, Inc. Bristol-Myers Squibb, Inc. Cambridge, MA Fort Worth, TX New Brunswick, NJ
Swanek, Franklin Vardon, Peter Winiarski, Pete Boehringer Ingelheim Food and Drug Administration McKinsey & Company Ridgefield, CT College Park, MD Florham Park, NJ
Sylvester, Stacie Vetter, Oliver Winkle, Helen IIR Bayer Health Care LLC Food and Drug Administration New York, NY Shawnee Mission, KS Rockville, MD
Szymczak, Margaret Vudathala, Gopi Winters-Heard, Cheryl GlaxoSmithKline Sanofi-Synthelabo Tyco Healthcare Mallinckrodt Philadelphia, PA Malvern, PA Saint Louis, MO
Taylor, John Wallace, Jon Wolfinger, John Food and Drug Administration CV Therapeutics Abbott Laboratories Rockville, MD Palo Alto, CA Abbott Park, IL
Taylor, Patricia Walton, Lori Wolszon, Jamie Depomed, Inc. US Army Med Res & Mat Cmd FDA Week Menlo Park, CA Frederick, MD Arlington, VA
Thakker, Purna Wang, Bosco Wong, Florence Pfizer, Inc. Fort Dodge Animal Health 3M Pharmaceuticals Morris Plains, NJ Princeton, NJ Saint Paul, MN
Thomas, Danita Ward, Teresa Wong, Geoffrey Oakwood Laboratories, LLC GlaxoSmithKline Food and Drug Administration Oakwood Village, OH King of Prussia, PA Rockville, MD
Till, Alice Wasserman, Jennifer Woodcock, Janet PhRMA Schering Plough Food and Drug Administration Washington, DC Kenilworth, NJ Rockville, MD
Trautman, Kimberly Watts, David Woods, Randall Food and Drug Administration Food and Drug Administration Food and Drug Administration Rockville, MD Rockville, MD Rockville, MD
Turton, Amanda Wechsler, Jill Woyshner, Jerome Millipore Corporation Pharmaceutical Technology US Food and Drug Bedford, MA Chevy Chase, MD Jamaica, NY
Tway, Patricia Welch, Karen Wu, Duu-Gong Merck & Co., Inc. CRS Food and Drug Administration Whitehouse Station, NJ Grayslake, IL Rockville, MD
Ukwu, Henrietta Whetstone, Sandra Yakush, William Merck Research Laboratories Food and Drug Administration Boehringer Ingelheim West Point, PA Rockville, MD Ridgefield, CT
Ulatowski, Timothy White, Gary Yamamoto, Grace Food and Drug Administration BioPort Corporation Eli Lilly and Company Rockville, MD Lansing, MI Indianapolis, IN
Uppoor, Rajendra White, William Yeh, Jerry Food and Drug Administration Eli Lilly and Company ALZA Corporation Rockville, MD Lafayette, IN Mountain View, CA
Vaid, Sonal Wilkinson, Neil Yu, Lawrence Food and Drug Administration AstraZeneca Pharmaceuticals Food and Drug Administration Rockville, MD Cheshire, United Kingdom Rockville, MD
VanDerWerf, Michael Wilkish, Kimberly Zell, Brant Aventis Behring Wyeth BioPharma Rhodia Pharma Solutions King of Prussia, PA Andover, MA Cranbury, NJ
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Page 10 of 11 A Drug Quality System for the 21st Century April 22-24, 2003 Listing of Attendees
Zenger, Vincent Food and Drug Administration Rockville, MD
Zimmer, Thomas Boehringer Ingelheim GmbH Ingelheim, Germany
Zinck, Barbara Cambrex Corporation Baltimore, MD
Zoltowski, Carol VIVUS, Inc. Mountain View, CA
Zumhofe, Jeff 3M Pharmaceuticals Saint Paul, MN
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