KC Animal Health
November 14 | 8:30am
Animal Health Regulatory 101

Regulatory affairs.gif

Animal Health Regulatory 101
An Introductory Course on the Regulatory Aspects of Animal Drug, Vaccine and Pesticide Development

Kansas State University Olathe campus
22201 W. Innovation Drive, Olathe, KS

November 13 | 8:30 a.m.- 4:30 p.m.
November 14  |  8:30 a.m.- 4:30 p.m.

Session Summary

This workshop on veterinary medicine regulations will provide attendees with an understanding of veterinary drug approval processes for all three regulatory agencies. Upon completing this course on veterinary medicine regulations participants will have learned:

  • The nature of jurisdiction over veterinary products between USDA, FDA, and EPA.
  • The veterinary approval process across FDA, USDA, and EPA
  • Various sections of a New Animal Drug Application (NADA - pioneer products) and Abbreviated NADA (ANADA - generic products)
  • Obtain working knowledge of the major and minor technical sections included within an FDA/CVM NADA or ANADA
  • Strategies and plans for navigating the FDA/CVM approval process
  • Discuss how to avoid common problems
  • Learn about and request ADUFA and AGDUFA fee waivers

More Information

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