Animal Health Regulatory Affairs workshop series begins, expands this fall

Wednesday, Aug. 18, 2021 | Written by Megan Gould


OLATHE — Back by popular demand, Kansas State University's Olathe campus is offering another round of professional development workshops in the campus' Regulatory Affairs Animal Health portfolio.

This year, in addition to the three ongoing animal health courses, the campus is expanding its reach by offering a new course focused on EPA product approval in agricultural and environmental industries.

“We are excited to offer the regulatory affairs for animal health professionals workshops this fall,” said Debbie Kirchhoff, executive director of strategic initiatives at K-State Olathe. "The workshops are designed to be interactive and deliver a practical understanding of the steps and key issues in the regulatory process for animal drug and vaccine approval and maintenance. Participants will gain knowledge about the regulatory process that they can use to advance their career and help their companies be successful.”

The workshops are designed for people tasked with developing and maintaining an animal health or agriculture company's product portfolio and are involved with a company's regulatory strategies. This includes individuals involved with regulatory affairs, research and development, veterinary product development, pesiticide development or conducting due diligence for product or company acquisition. Workshops are offered online or in person.

The three core workshops this fall are:

Animal Health Regulatory 101 is 8:30 a.m. to 4:30 p.m. Sept. 22-23. This introductory, two-day workshop is an interactive course on the regulatory aspects of animal drug and vaccine development, providing attendees with an understanding of the veterinary drug approval processes. Attendees will learn how to navigate the U.S. Food and Drug Administration and the U.S. Department of Agriculture, the two federal agencies that oversee these products.

The Animal Health Advanced Biologics Workshop is from 8:30 a.m. to 4:30 p.m. Oct. 20-21. This workshop covers 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. Attendees will learn the history of applicable regulations implemented by the USDA’s Center for Veterinary Biologics and will gain an understanding of the integration of science into successful product approval and maintenance.

The Animal Health Advanced Pharmaceuticals Workshop is from 8:30 a.m. to 4:30 p.m. Nov. 17-18. This advanced workshop provides a detailed, practical and experience-based review of the veterinary drug approval process. The content of this course covers five topics that comprise the four major technical sections of a product submission to the FDA’s Center for Veterinary Medicine — chemistry, manufacturing and control; efficacy; target animal safety; human food safety; and efficacy for generic products.

New this fall is a course focused on the U.S. Environmental Protection Agency, or EPA, and the role it plays in product approval in agricultural and environmental industries.

Pesticide Regulatory Affairs: EPA Approval Process is from 9 a.m. to 4 p.m. Oct. 6. This workshop will provide a basic overview of the regulation of pesticide products by the EPA. The material covered will present registration strategies from the perspectives of both the animal health industry as well as the agency, and will use case studies to highlight common pitfalls and challenges faced along the way.