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Dr. Kristi Olson Smedley
Resumè
EDUCATION:
Doctorate of Philosophy--Virginia Polytechnic Institute and State
University (Animal Nutrition and Forage Science)--1986
Masters of Science--Virginia Polytechnic Institute and State University
(Animal Nutrition)--1982
Bachelor of Science--The Pennsylvania State University
(Biology)--1980
PRESENT POSITION:
Consultant, Center for Regulatory Services (1996-present). I
provide consulting services to pharmaceutical, food, and pesticide firms
with a primary emphasis on product development and regulatory compliance.
I have a broad understanding of FDA-related regulations, current guidance,
and extensive experience in clinical study development and conduct in
animal research.
EXPERIENCE:
Chief, Petitions and Regulations Staff, Division of Compliance, Center
for Veterinary Medicine, Food and Drug Administration (1993-1996). I
supervised a staff whose varied duties included, drafting new animal drug
approval regulations, procedural regulations, and policy documents,
interpreting of the Federal Food Drug and Cosmetic Act and other related
laws, regulations, and guidances, and overseeing policy development.
Examples of regulations or guidances that I developed or supervised the
development of, include: the implementing regulations for the Animal
Medicinal Drug Use Clarification Act of 1994, the agencys regulations
regarding the use of animal-derived feed products to reduce the risk of
TSEs in the United States, and guidances regarding debarment, the
application integrity policy, and clinical studies. I was also responsible
for the coordination of the clearance of all CVM-generated FEDERAL
REGISTER documents (rules and notices). In addition, I was the team leader
for many other CVM projects that were not related to regulation or policy
development.
Consumer Safety Officer, Petitions and Regulations Staff, Center for
Veterinary Medicine, Food and Drug Administration (1990-1993). My
duties were as described above, excluding supervision of personnel.
Examples of specific projects conducted during this time include:
implementation of the agencys Application Integrity Policy as it relates
to animal drug applications, drafting guidance related to the monitoring
and conduct of clinical investigator studies, oversight of the audits of
applications administered under the application integrity policy, drafting
procedural regulations, and drafting notices of opportunity of hearings.
Animal Scientist, Petitions Review & Medicated Feeds Branch, Center
for Veterinary Medicine, Food and Drug Administration (1987-1990). My
duties were to review and respond to food additive petitions, generally
recognized as safe petitions, and informal advisory petitions related to
animal products. During this time, I formulated the Centers position on
biotechnologically-derived animal foods and food additives. In addition, I
coordinated the agencys response to challenges related to the use of
selenium in animal feeds.
Private Contractor for the United States Department of Agriculture
(1985-1986). I provided statistical and laboratory analyses related to
animal and forage studies.
HONORS and AWARDS:
FDA AWARDS:
May, 1997-Group Recognition Award-Animal Medicinal Drug Use
Clarification Act Implementation.
May, 1996-Group Recognition Award-Strategic Planning Group
May, 1995-Group Recognition Award-Bovine Spongiform Encephalopathy
Working Group
May, 1994-Group Recognition Award-Selenium Evaluation Team
May, 1994-Group Recognition Award-Financial Disclosure group
May, 1993-Commendable Service Award-Outstanding and exceptional
contributions to the Center for Veterinary Medicine
May, 1993-Group Recognition Award-Pen-Strep Desi Finalization Group
Outstanding Evaluations-1987, 1989, 1991, 1992, 1993, 1994, and
1995
OTHER:
John Lee Pratt Fellowship for Outstanding Animal Nutrition
Students-1981-1985 (full graduate scholarship)
PROFESSIONAL MEMBERSHIPS:
Member, American Society of Animal Science
Member, American Registry of Professional Animal Scientists
(past-treasurer)
REFERENCES:
Available upon request
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