Curriculum Overview for the Animal Health Regulatory Affairs Graduate Certificate

The Animal Health Regulatory Affairs Graduate Certificate is designed to meet a long-standing industry need in the animal health industry. Regulatory affairs requires a specialized skill set, which combines the knowledge of animal science and veterinary medicine, with skill in navigating governmental processes and regulations.

In addition to faculty instructors, several of the courses bring in industry professionals to lead in-depth discussions of key topics.

AAI 840 - Regulatory Aspects of Drug and Vaccine Development in the Animal Health Industry

2 Credit Hours

Faculty Instructor: Douglas Shane, Ph.D., D.V.M.

This course explores the topic of regulations associated with animal health product development and manufacturing. Topics for discussion will include an overview of the regulatory affairs process in the U.S. and other countries, drug and vaccine classifications and the approval process, GCP/GLP guidelines, drug and vaccine efficacy and safety testing, human and environmental safety issues, and future challenges and current industry needs.

 

STAT 703 - Introduction to Statistical Methods for the Sciences

3 Credit Hours

Faculty Instructor: TBA

Statistical concepts and methods applied to experimental and survey research in the sciences; tests of hypotheses, parametric and rank tests; point estimation and confidence intervals; linear regression; correlation; one-way analysis of variance; contingency tables, chi-square tests.

 

AAI 841 - Strategies in Preclinical and Clinical Research for Regulatory Affairs in Animal Health

2 Credit Hours

Faculty Instructor: Haley Larson, Ph.D.

In this course, students will review the history of regulations as well as gain an understanding of the integration of science into successful product approval outcomes. Students will learn how to achieve target claims for developing new products while ensuring safety. Students will also be introduced to the planning, design, and conduct of preclinical and clinical studies. The topics covered include protocol design and the evaluation and assessment of regulatory submissions. The course will consider practical issues in regulatory affairs. Students may participate in case study exercises.

 

AAI 842 - Strategies in the Stewardship of Licensed Pharmaceuticals and Biologics in Animal Health

1 Credit Hour

Faculty Instructor: Douglas Shane, Ph.D., D.V.M.

In this course, students will learn about the role of regulatory affairs in stewardship of animal health products. The topics covered include expected activities primarily post product approval, compliance, strategies for supply management, product life cycle management, risk management, and the role of industry in policy development. Communication with various stakeholders, including regulatory agencies, research and development, manufacturing, and marketing and sales are covered. The course will consider practical issues in regulatory affairs. Students may participate in case study exercises.

 

AAI 843 - Regulatory Development of Animal Pharmaceuticals — FDA

2 Credit Hours

Faculty Instructor: Douglas Shane, Ph.D., D.V.M.

In this course, students will focus on the regulatory strategies that support product development and maintenance regulated by the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). This includes product development strategies based on clinical and nonclinical data, key manufacturing and supply chain regulations, and post approval product life cycle management, including pharmacovigilance. Variances between food animal and non-food animal targets in developing regulatory strategies will be reviewed. Special topics, current topics and FDA enforcement actions will be covered. Students may participate in case study exercises.

 

AAI 844 - Regulatory Development of Animal Pesticides — EPA

2 Credit Hours

Faculty Instructor: Haley Larson, Ph.D.

In this course, students will focus on the regulatory strategies for the development of products deemed to be regulated by the Environmental Protection Agency (EPA). This course will focus on product development strategies, manufacturing and supply chain regulations, and post marketing product life cycle management, including pharmacovigilance. Environmental laws and risk assessment will also be covered. Students may participate in case study exercises.

 

AAI 845 - Regulatory Development of Animal Biologicals and Diagnostics — USDA

2 Credit Hours

Faculty Instructor: Paige Adams, Ph.D., D.V.M.

In this course, students will focus on the structure and detailed approach for developing animal biologicals and diagnostics regulated by the United States Department of Agriculture (USDA). Students will gain solid understanding of the critical pathway to successful product development, manufacturing, compliance, and product life cycle management, including post marketing surveillance. The course also addresses adapting new technology to emerging and re-emerging diseases. Students may participate in case study exercises.

 

AAI 846 - Special Topics: Regulatory Affairs in Animal Health

1 Credit Hour

Instructed by various K-State Olathe faculty members

This course is the assessment piece in the Animal Health Regulatory Affairs graduate certificate program and will be used as the final culminating experience. Students will be required to complete a final project that integrates learning following the completion of program courses.

The prerequisites for this course are AAI 840, AAI 841, AAI 842, AAI 843, AAI 844, AAI 845 and STAT 703 or advisor approval.