Animal Health Regulatory Affairs Graduate Certificate
Confidently manage multimillion dollar animal health products as you navigate federal agencies, compliance laws and communications across internal and external units throughout product development to market release and beyond.
Regulatory affairs is a critical component of the growing animal health industry. This graduate certificate program in regulatory affairs is based on industry input and exclusively tailored to the animal health industry.
This 15 credit hour Regulatory Affairs graduate certificate provides a series of courses and experiences that will help equip animal health professionals with the tools and knowledge needed to navigate governmental processes and regulations.
- No required prerequisites
- 16 week courses, available after business hours
- Full-time faculty and guest lecturers with industry experience
- May start coursework any semester during the year
- No out-of-state tuition and fees
The total for this 15 credit hour certificate program is approximately $8,500.
The increasing complexity of the global animal health industry has created the need for enhanced training of employees involved in various aspects of the regulatory pathway.
- Enhanced understanding of the policies and regulatory requirements for USDA, FDA and EPA
- Role of regulatory affairs in all aspects of business
- Effective communication with regulatory agencies
- Product lifecycle development and maintenance
- GXP, validation, study design and applied statistics, including requirements for different regulators
- Regulatory compliance
- Global strategies including historical perspectives, social aspects and methods to ensure product safety
This certificate is ideal for working professionals who want to:
1) Demonstrate comprehensive understanding of the regulatory process and strategy for products approved by the FDA/EPA/USDA.
2) Identify the extent to which clinical research protocols establish the efficacy and safety of products compliant with regulatory guidelines for product development.
3) Synthesize regulatory requirements with effective business practices while operating in a compliant manner.
Regulatory affairs professionals have varied backgrounds, with many trained in the biosciences, manufacturing or technical writing. This graduate certificate is for professionals with a bachelor's degree in a variety of fields.
|AAI 840. Regulatory Aspects of Drug and Vaccine Development in the Animal Health Industry|
|AAI 841. Strategies in Preclinical and Clinical Research for Regulatory Affairs in Animal Health|
|AAI 843. Regulatory Development of Animal Pharmaceuticals - FDA|
|AAI 845. Regulatory Development of Animal Biologicals and Diagnostics - USDA|
We understand you may have a lot of questions about this certificate and going back to school. Check out some of the frequently asked questions about the Regulatory Affairs Animal Health Graduate Certificate.
- Official transcripts for all undergraduate coursework (minimum 3.0 GPA required)
- Official transcripts for all graduate coursework
- A completed application to the K-State Graduate School. This application has a $50 fee. Attend a webinar or info session and receive a code to waive this application fee.
Please note that graduate students must be seeking a degree to qualify for federal financial aid loans.
Positions and job duties include:
"There is a continuous demand for highly educated professionals who specialize in regulatory affairs. That demand for talent won't ever slow down. If anything, the need is increasing as the industry continues to discover new pharmaceuticals, therapeutics and products that improve animal health."
— Bill Zollers, vice president for regulatory affairs for North America at Norbrook Inc.