Three animal health regulatory workshops offered as professional development opportunities

Friday, Feb. 12, 2021 | Written by: Megan Gould

 

OLATHE — This spring, Kansas State University's Olathe campus is offering three professional development workshops as part of the campus' ongoing Regulatory Affairs Animal Health program. These workshops cover the regulatory aspects of animal drug and vaccine development, with options for introductory and advanced courses.

“We are pleased to offer another round of regulatory workshops for animal health professionals this spring,” said Angela Buzard, manager of training and development at K-State Olathe. "The workshops are designed to deliver a practical understanding of the steps and key issues in the regulatory process for animal drug and vaccine approval and maintenance. Education of this type is making a positive impact in the field as this was a previously unmet need.”

Animal Health Regulatory 101 is 8:30 a.m. to 4:30 p.m. April 7-8. Back by popular demand, this two-day interactive workshop is an introductory 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. May 26-27. 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. June 16-17. This advanced workshop provides a detailed, practical and experience-based review of the veterinary drug approval process. Content 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.

All three workshops are designed for people tasked with developing and maintaining an animal health company's product portfolio and are involved with a company's regulatory strategies. This includes individuals involved with regulatory affairs, veterinary product development, or conducting due diligence for product or company acquisition. Workshops are currently offered online only.

The workshops are part of the campus' ongoing Regulatory Affairs Animal Health Program, which provides the latest information about the regulatory field through workshops and seminars. More than 500 professionals from animal health companies and affiliated industries have attended program events since it launched in 2017.