There are four courses that comprise the certificate program.
This course provides a working knowledge of the laws and regulations relating to the governance and activities of the US FDA. The course focuses on the various ways that science informs regulatory actions, as well as the laws, regulations, and policies used by the FDA to ensure the safety of medical products, food, and cosmetics.
Methods in Product Safety Assessment/Risk Assessment
This course provides a systematic approach to current and emerging practices for assessing safety and risks from drugs and other chemicals. In this course, students study the utilization of risk assessment frameworks by federal regulatory agencies, especially the FDA. Students also study and put into practice the basic principles and methods used to quantify or predict human risk, including dose-response assessments and topics relevant to estimating human health risk from regulated consumer products.
Clinical Trials Design and Management
This course examines the design and conduct of clinical trials from the perspectives of investigators, sponsors, and regulators. Basic principles of study design are reviewed and applied, and contemporary issues in study design and management are considered. Students gain experience in developing a clinical trial protocol within a team-based environment that will simulate project development in the pharmaceutical industry.
Good Regulatory Practices
This course examines FDA and ICH regulations on good laboratory practices (GLPs), good clinical practices (GCPs), and good manufacturing practices (GMPs). This includes the globalization of practices and the roles and responsibilities of various professionals implementing these regulations. Emphases include the process for the assembly and submission of proposals for a new drug or medical device (IND or NDA); the function of the regulatory affairs department in a pharmaceutical company; and data quality issues required for regulatory decision-making.
In order to be properly prepared for the program, students must demonstrate prior coursework or professional experience in Biostatistics and Toxicology/Pharmacology. Since our students come from diverse scientific backgrounds, specializations, and professional settings, applicants not meeting these prerequisite requirements may be admitted conditionally.
If conditional admittance is granted, proficiency in Biostatistics and Toxicology/Pharmacology must be demonstrated before the Certificate in Regulatory Science is awarded. UAMS offers graduate courses in Toxicology, Biostatistics, and Pharmacology, and a tutorial in Biostatistics and Toxicology will become available. Other methods used by the applicant to obtain proficiency will be considered on a case-by-case basis.
For more information on our courses, visit our Course Catalog .