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K-State Olathe

K-State Olathe
22201 W. Innovation Dr.
Olathe, KS 66061-1304

913-541-1220
913-541-1488 fax
olatheinfo@k-state.edu

Regulatory Affairs in Animal Health Seminar Series

Throughout the 2017-2018 academic year, K-State Olathe is hosting four seminars tailored to the Kansas City area animal health regulatory affairs community. The series is aimed at providing hot topic information in regulatory affairs and connecting industry with regulatory agencies. 

"Ensuring Data Quality in Animal Health Studies"

March 6, 2018 | 1-5 p.m.
Animal health studies submitted to FDA for product approval have a multipart process from study design to report submission. Ensuring data quality along this process is critical for successful submission and product approval. This seminar will discuss CVM’s perspective on the common issues encountered by reviewers and ways to achieve one-cycle reviews. Additionally, lessons learned and best practices will be shared from the industry and academic perspectives to help in the process.
Highlighted speakers

Annette Kenser, SQA AHSS chair and lead quality auditor, Bayer Animal Health

 Fredda Shere-Valenti, SQA AHSS co-chair, retired compliance officer, CVM/FDA

 Heather Raszka, research and development senior specialist, Quality Assurance Unit, Boehringer Ingelheim

• Kelly Lechtenberg, D.V.M., Ph.D., Veterinary and Biomedical Research Center

 David Renter, professor and director for the Center for Outcomes Research and Epidemiology, College of Veterinary Medicine, Kansas State University

Officials at the FDA Center for Veterinary Medicine also have been invited. 

 

Register Now

 


Previous seminar

"Regulatory Challenges Associated with New Technology Implementation" | Dec. 7, 2017


Below are presentations from seminar speakers. 

Innovating in Food Producing Animals in the New Age of
"Clean Food"
Scott Holmstrom, Ph.D., senior director, Food and Animal Product Development, Elanco Animal Health


Regulatory Challenges in Food Animal Drug Development
Michael Apley, D.V.M., Ph.D., DACVCP, Frick Professor of Clinical Sciences, College of Veterinary Medicine, Kansas State University


Modern Approaches to Provide Data to Regulatory Agencies

Butch KuKanich, D.V.M., Ph.D., Diplomat ACVCP, professor and assistant department head, College of Veterinary Medicine, Kansas State University


Regulation of Novel New Animal Drugs
Heather Lombardi, Ph.D., Animal Bioengineering and Cellular Therapies team leader, Office of New Animal Drug Evaluation, Food and Drug Administration's Center for Veterinary Medicine  

Next seminar

March 6, 2018
"Ensuring Data Quality in Animal Health Studies"