Regulatory requirements for animal drugs and vaccines are topics of upcoming workshops

Monday, June 22, 2020

OLATHE – Three professional development workshops about regulatory affairs in animal health are being offered this fall by Kansas State University's Olathe campus.

Workshops cover the regulatory aspects of animal drug and vaccine development, with options for introductory and advanced courses.

"We are excited to bring together leading professionals in the regulatory field and provide education for an unmet need in the animal health industry," said Angela Buzard, manager of training and development at K-State Olathe. "This set of workshops, as well as previous seminars on similar topics, are making a positive impact. We look forward to continuing to work with industry partners to launch additional programs as new needs arise."

Animal Health Regulatory 101 is 8:30 a.m. to 4:30 p.m. Aug. 26-27. It is a two-day introductory course on the regulatory requirements of animal drug and vaccine development. 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. They also will learn about the requirements the agencies place on the development and maintenance of drugs and vaccines.

This workshop returns because of popular demand. Twenty-four participants from 12 animal health companies attended the previous workshop and scored it a 4.48 on a 5.0 scale. Several of these companies contacted K-State Olathe to ask about the next offering to send additional employees.

The Advanced Animal Biologics Workshop is from 8:30 a.m. to 4:30 p.m. Oct. 21-22. The 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 about the history of applicable regulations used by the USDA's Center for Veterinary Biologics and gain an understanding of the integration of science into successful product approval and maintenances.

The Advanced Animal Pharmaceutical Workshop is from 8:30 a.m. to 4:30 p.m. Nov. 11-12. This workshop provides a detailed, practical and experience-based review of the veterinary drug approval process. Content covers the 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 have content is designed for professionals who are tasked with developing and maintaining an animal health company's product portfolio or who are involved with the company's regulatory strategies.

The workshops can be attended in-person at the Olathe campus or virtually. Those who attend on campus are required to practice social distancing to aide in participant safety.

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 400 professionals from animal health companies and affiliated industries have attended program events since it launched in 2017.