Course offering number:0903-407
Course ID:
587
U.S. FDA Drug Development and Compliance
March 23-25, 2009
New Brunswick, NJ
Mary L. Richardson; Vice President Regulatory Affairs, Mission Pharmacal Company
Mary L. Richardson is currently Vice President Regulatory
Affairs at Mission Pharmacal Company. She oversees all the
company’s prescription and OTC drugs, medical devices and
dietary supplement production for domestic and international
regulatory operations to assure compliance with all applicable
requirements. Prior to this industry position, Ms. Richardson
worked for twenty-one years with FDA, beginning in the New
Jersey district office as a consumer safety officer. She served
in the Commissioner’s Office of Legislative Affairs in both the
congressional oversight areas of drugs and foods and the
legislative section which develops and analyzes pending
legislation affecting FDA. Ms. Richardson held the position of
Deputy Director in the Office of Drug Compliance in the
Division of Drug Labeling Compliance for prescription and
OTC drugs and as Deputy in the Division of Scientific
Investigations, directing FDA activities in the bio research
monitoring programs.
Gary L. Yingling, Esq.; Partner, K&L Gates
Gary L. Yingling, Esq. is a Partner with the law firm of K&L
Gates. Prior to entering private practice he was, for nine years,
President of the Food and Drug Law Institute. Mr. Yingling
served in government for ten years, primarily in FDA’s Office of
General Counsel as a trial attorney and, later, as Associate
Chief Counsel for Veterinary Medicine and Deputy Chief
Counsel for Administration. He also served as Director of
FDA’s Over-the-Counter Drug Review. Mr. Yingling received
his B.S. in Pharmacy from the University of North Carolina,
an M.S. in Pharmacology from Purdue University, and his
law degree from Emory University. He is counsel to the
International Society for Regulatory Toxicology and
Pharmacology, is Editor of the Guide to Good Clinical
Practices, and serves on the Editorial Board of both the
Clinical Research Practices and Drug Regulatory Affairs and Regulatory Toxicology and Pharmacology journals
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