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Certificate in Regulatory Science

Overview

The Graduate Certificate in Regulatory Science consists of 12 semester credit hours with courses in current regulatory statutes, safety assessment, clinical trials design and management, and data quality requirements for regulatory decision-making.

This program is supported by the Department of Environmental and Occupational Health.

Benefits of the Graduate Certificate in Regulatory Science

The need for increased training in Regulatory Science is highlighted in a recent Institute of Medicine (IOM) report entitled, “Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary” (2011). The needs described in the IOM report parallel those described in the FDA Strategic Plan document, “Advancing Regulatory Science at FDA” (2011) which emphasized the need for increased training in Regulatory Science.

The Certificate in Regulatory Science provides an extension to the PhD student’s existing toxicology/pharmacology training. The Certificate in Regulatory Science  provides the fellows or students a unique component to their training that sets them apart from other classically trained scientists when seeking employment opportunities, whether they seek jobs in governmental regulatory agencies, regulated industries, or academia.

The Certificate in Regulatory Science serves both full-time and part-time students interested in expanding their knowledge of regulatory science. The training provides a more competitive background for regulatory science-based careers.

A primary goal of the program is to provide students with insight into the complexities of the laws, regulations, policies, risk assessments, risk-benefit analyses and risk management processes. This training provides graduates with a working knowledge of regulatory science and provides leaders in regulatory science for industry, government, and academia.

The course structure ultimately will include a distance learning format. The distance learning option will provide students with the same content and resources that are provided for those students who attend traditional didactic classes. The distance learning option will expand the geographic reach of the certificate and graduate programs to a national and international scope.

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Admissions Requirements

Students for the Certificate in Regulatory Science are recruited from existing pools of potential students. The first is comprised of post-doctoral ORISE fellows training in the research laboratories at NCTR. The second is made up of regular FDA employees at the FDA’s Jefferson Laboratories. A third group includes entering and current students enrolled in the Ph.D. programs at UAMS, particularly students pursuing the Ph.D. in toxicology or pharmacology.

Requirements of the Department of Environmental and Occupational Health

NCTR and ARL Affiliated Applicants

1. A letter from the applicant, on FDA Letterhead, stating that the applicant wishes to be accepted into the Certificate in Regulatory Science program. The letter will be addressed to the Certificate in Regulatory Science Training Coordinator, Attention: Morris Cranmer, Ph.D., UAMS, and 4301 W. Markham St., Slot 820-11, Little Rock, AR 72205-7199.

2. The applicant’s CV.

3. A copy of the applicant’s Ph.D., ScD., D.Sc., S.D, Dr.Sc., M.D. or D.V.M degree diploma and an unofficial transcript. In the case of applicants without a doctorate, an official transcript showing award of the applicant’s B.S., B.A. or M.S. degrees.

4. A letter of recommendation from the applicant’s Division Chief or Laboratory Director.

5. A transcript listing a graduate course in Toxicology and Biostatistics; or documentation of other equivalent formal training or continuing education; or a letter from the applicant’s Division Chief or Laboratory Director stating that the applicant is proficient in Toxicology and Biostatistics.

Applicants not meeting the prerequisite requirements in Toxicology and Biostatistics may be admitted conditionally but only after an interview with the Certificate in Regulatory Science Coordinator. Conditional admittance will usually be granted; however, proficiency in Toxicology and Biostatistics must be demonstrated before the Certificate in Regulatory Science is awarded. Successful completion of the Risk Assessment Course with a grade of B or better adequately demonstrates proficiency. UAMS offers graduate courses in Toxicology and Biostatistics. A tutorial in biostatistics and toxicology will become available. Other methods used by the applicant to obtain proficiency shall be approved on a case-by-case basis by the Certificate in Regulatory Science coordinator.

Graduate Students in Other UAMS Departments and Programs

All UAMS Graduate Students may enroll in Regulatory Science courses with the permission of their advisor and the course director.

Graduate students wishing to receive a Certificate in Regulatory Science will provide to the Certificate in Regulatory Science Coordinator:

  • A letter from the applicant, on UAMS Letterhead, stating that the applicant wishes to be accepted into the Certificate in Regulatory Science program.
  • The applicant’s CV.
  • A copy of the applicant’s transcript;
  • A letter of recommendation from the applicant’s major professor/advisor, program director or department chair.
  • If not on the applicant’s transcript proof of taking graduate courses in Toxicology and Biostatistics.
  • Applicants not meeting the prerequisite requirements in Toxicology and Biostatistics may be admitted conditionally but only after an interview with the Certificate in Regulatory Science Coordinator. Conditional admittance will usually be granted; however, proficiency in Toxicology and Biostatistics must be demonstrated before the Certificate in Regulatory Science is awarded. UAMS offers graduate courses in Toxicology and Biostatistics.

Materials required by the Certificate in Regulatory Science may be delivered:

  • In person to room 1227 College of Public Health, UAMS.
  • By US mail, to Morris Cranmer, Ph.D., 4301 Markham St. #820-11 Little Rock, AR 62205-7199.
  • Emailed to mcranmer@uams.edu
  • Faxed to 501-526-6750 ATTN: Morris Cranmer, Ph.D. Professor of Environmental and Occupational Health.

UAMS Graduate School Admission Requirements

Applicants for the Certificate in Regulatory Science must obtain admissions information from and follow admissions procedures established by the UAMS Graduate School . The Graduate School will accept documents required by the DEOH.

The Graduate School requires a Certificate of Resident Status. A wavier of Resident Status based on visa status may be considered on a case-by-case basis.

How to Apply

For More Information:

Morris Cranmer, Ph.D.
Department of Environmental and Occupational Health
4301 Markham St. #820-11
Little Rock, AR 72205-7199
Phone: 501.526.6696
Email:mcranmer@uams.edu