Foundational knowledge in animal health regulations for drugs, biologics, and medical devices. Animal Health Regulatory will cover the life cycle of animal health products from discovery through development, registration, and commercialization of the products including product stewardship and management of products.
Athena Title
Animal Health Regulatory
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
PHAR 6010 or PHAR 6010E or permission of department
Grading System
A - F (Traditional)
Student learning Outcomes
Students will demonstrate an understanding of the animal health industry paradigm that includes a range of species, different dosage forms, multiple modalities of treatment, and different regulatory frameworks depending on which Agency regulates the different treatment modalities.
Students will define the global development process and safety, efficacy, and quality requirements for animal drugs including medicated feeds and animal biologics including vaccines, companion animal pesticides, and medical devices including diagnostics.
Students will explain the VICH requirements for registration of veterinary products. Outline the key regulatory differences between the US and other markets that may need to be considered when developing animal health products.
FDA – Center for Veterinary Medicine (CVM)
i. Describe the organizational structure of CVM and the Federal Food, Drug, and Cosmetic Act (FFD&C).
ii. Explain the regulatory and study requirements for registration of pioneer and generic animal drugs and medicated feeds with FDA/CVM.
iii. Outline the submission and approval process for pioneer and generic animal drugs and medicated feeds with FDA/CVM.
iv. Summarize the FDA User Fee and electronic submission process.
v. Outline the activities required to maintain the products on the market once approved.
vi. Explain the requirements for medical devices used in the animal health industry and the FDA oversight framework.
USDA – Animal and Plant Health Inspection Service (APHIS) – Center for Veterinary Biologics (CVB)
i. Describe the organizational structure of USDA/APHIS/CVB and Virus, Serum, and Toxin Act (VTSA).
ii. Explain the regulatory and study requirements for licensing of vaccines and other biologicals.
iii. Describe the submission and licensing process for vaccines and other biologics.
iv. Summarize the electronic submission process to USDA.
v. Outline the activities required to maintain the product on the market once licensed.
vi. Determine the requirements for in vitro diagnostic devices and the role of USDA and CLIA in the development of these devices.
EPA – Office of Pesticide Programs (OPP)
i. Describe the organizational structure of EPA/OPP.
ii. Outline the registration and study requirements for pesticides.
iii. Describe the submission and registration process for manufacturing-use products, end-use products, and me-too products.
iv. Summarize the PRIA (Pesticide Registration and Improvement Act) fees and electronic submission process to EPA.
v. Explain the activities required to maintain the product in the market once registered and activities related to re-registration.
Students will explain the principles of Pharmacovigilance. Compare and contrast the differences in the pharmacovigilance requirements for FDA, USDA, and EPA including signal detection and adverse event trending and reporting requirements.
Students will delineate the jurisdictional overlaps between FDA and USDA for biopharmaceuticals, and between FDA and EPA for chemicals that can meet the definition of both the drug and pesticide.
Students will explain the basis for labeling and product claim approvals and the regulated use of these in product promotion.
Topical Outline
The Animal Health Regulatory Course will cover the life cycle of animal health products from discovery through development, registration, and commercialization - including product stewardship and post-approval management.
Many animal health products are developed for marketing globally, and this course will provide an understanding of the global development requirements for major modalities of use such as animal drugs (including medicated feeds), vaccines and other biologicals, pesticides, and medical devices (including diagnostics).
The course will focus on the United States regulatory framework where animal health products are regulated by the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the varying requirements for registration, processes for obtaining marketing authorizations, and post-approval commitments and requirements to maintain products on the market.
The broad scope of the course will provide veterinary students, other graduate students, and working professionals with knowledge and background to support roles and employment in the animal health industry.
