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Online Training Seminar

"The FDA Process for Approving Generic Drugs"

June 2007

(No Credit Is Offered)

BIOGRAPHIES OF SPEAKERS:

Gary Buehler
Gary Buehler was appointed Director, Office of Generic Drugs, Center for Drug Evaluation and Research, in July of 2001. He had held the position of Deputy Director, Office of Generic Drugs, since May of 1999. Mr. Buehler has worked for FDA since 1986. Prior to joining the Office of Generic Drugs, he was a Senior Regulatory Project Manager in the Division of Cardio-Renal Drug Products in the Office of New Drugs. Mr. Buehler retired from the United States Public Health Service (USPHS) in April of 2000. He served at a variety of duty stations in the USPHS Division of Hospitals and Clinics as well as serving in the Indian Health Service in Nevada and Montana before coming to FDA. He graduated from Temple University School of Pharmacy.

Dale P. Conner
Dr. Conner received his B.Sc. in Pharmacy from the Massachusetts College of Pharmacy in 1979, and a Pharm.D. in 1983 from the University of Florida. From 1983 to 1985, he completed a postdoctoral fellowship in Clinical Pharmacology in the Division of Clinical Pharmacology of Thomas Jefferson University. He then joined the faculty of the Uniformed Services University of the Health Sciences as an assistant, and later associate, professor in the Division of Clinical Pharmacology. From 1992 to 1994, he was Director of Pharmacokinetics for Scios Nova, Inc. From 1995 to 1997, he held the position at FDA of Team Leader for Clinical Pharmacology and Biopharmaceutics in the areas of pulmonary, allergy, drug abuse, anesthesia and critical care drug products. His current position is Director of the Division of Bioequivalence, Office of Generic Drugs, FDA. He is board certified in Applied Pharmacology by the American Board of Clinical Pharmacology. Research interests have included pharmacokinetics, drug metabolism, analytical methods, transcutaneous measurement of drugs, measurement of drug effects on the skin, and drug therapy of sepsis and ARDS.

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