The U.S. Department of Agriculture's Center for Veterinary Biologics (USDA CVB) regulates veterinary biologics available for the diagnosis, prevention and treatment of both companion and food producing animals. This workshop will cover practical issues in animal health regulatory affairs as it relates to the development of vaccines and other biologics to aid in assuring developed biologics are pure, safe, potent and effective. The workshop will provide a history of applicable regulations and an understanding of the integration of science into successful product approvals. Instruction will include: How to achieve target label claims for developing new products, while ensuring the product is pure, safe and effective; the planning, design and requirements for conducting pre-clinical and clinical trials; protocol design and the evaluation and assessment of the regulatory submission; as well as the requirements following licensure of the product will also be presented. The course will be delivered in an interactive format to encourage group learning and will be based on experience and practical industry examples. Participants can attend the training in person or virtually. For those that plan to participate on-campus, all recommended social distancing practices will be in place to aide in participant safety.

The U.S. Food and Drug Administration's Center for Veterinary Medicine, or FDA CVM, is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. This workshop on veterinary medicine regulations will provide attendees with a detailed, practical and experienced based review of veterinary drug approval processes. It will be focused on four major technical sections (5 topics) of an FDA CVM product submission: Chemistry, Manufacturing, & Control (CMC); Efficacy; Target Animal Safety; Human Food Safety (HFS); and Bioequivalence (safety and efficacy for generic products). Participants can attend the training in person or virtually. For those that plan to participate on-campus, all recommended social distancing practices will be in place to aide in participant safety.