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Study Data Exchange Standards for Study Data Submitted to the Center for Veterinary Medicine/U.S. Food and Drug Administration
By: Rob Hunter, Animal Health Lead Instructor and Advisor on the topic of animal health regulatory affairs So, what are data exchange standards? And, why is Center for Veterinary Medicine (CVM) and the U.S. Food and Drug Administration (FDA) requesting input regarding them? Well, on the Center for Drug Evaluation and Research – or CDERContinue reading “Study Data Exchange Standards for Study Data Submitted to the Center for Veterinary Medicine/U.S. Food and Drug Administration”
Animal Health Advanced Pharmaceutics Regulatory Workshop
Welcome back to the YourCareerEdge Blog. Here’s another contribution from Rob Hunter, Animal Health Lead Instructor and Advisor on the topic of animal health regulatory affairs. Rob and his partners Stephanie Batliner and Dr. Karen Fuller share their perspectives on the K-State’s upcoming pharmaceuticals workshop. The Advanced Pharmaceutics Regulatory workshop was first held at K-StateContinue reading “Animal Health Advanced Pharmaceutics Regulatory Workshop”
Certificate of Pharmaceutical Product Modernization
Dr. Rob Hunter, animal health lead instructor and advisor on the topic of animal health regulatory, is back to share his insights on a recent update in the field. Well, it is that time again. I thought I would review and comment on some recent CVM/FDA announcements, plans and new GFIs. On December 11, 2020 theContinue reading “Certificate of Pharmaceutical Product Modernization”
K-State Professional Development and Animal Health Regulatory 101
Welcome back to the YourCareerEdge Blog. Here’s another contribution from Dr. Rob Hunter, animal health lead instructor and advisor on the topic of animal health regulatory affairs. Rob shares his perspective on the Regulatory 101 workshop he co-teaches with Norm Brown. “Animal Health Regulatory 101” was first held at K-State Olathe in November of 2019.Continue reading “K-State Professional Development and Animal Health Regulatory 101”
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Cutting through the animal health regulatory alphabet
A brief history of how the series came to be and how to navigate the animal health industry’s acronyms and abbreviations.
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