Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies

7 - 8 May 2015, United States

Course Description:

Studies of veterinary drugs are required to be conducted under VICH Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) for approval by the various regulatory agencies. Clinical trial monitoring, quality audit procedures, collection of valid data, and conduct of both clinical trials and target animal safety studies are regulatory requirements. Additionally, the FDA inspects studies submitted for regulatory approval. Understanding core concepts of veterinary drug studies is vital for organizations and personnel involved with submitting studies to regulatory agencies.

In this 1.5 day workshop conference you will learn the concepts of VICH GCP, recognize the difference between GCP and GLP and when each is used, gain an understanding of Target Animal Safety studies, and gain tools and procedures for writing clinical trial protocols, implementing quality auditing procedures, monitoring clinical trials, and assessing data validity. Practical exercises will be used to illustrate data validity and monitoring tools. Additionally, tips for managing FDA inspections of clinical trials will be presented.

Learning Objectives:

Upon completing this course participants should:

Understand the concepts of VICH GCP
Recognize the similarities and differences between GCP and GLP and their application to trial types
Understand how GLPs can be implemented
Understand Target Animal Safety studies and the structure and requirements of margin of safety studies
Have tools to write good clinical trials protocols
Understand the differences between quality audit procedures and quality assurance procedures
Understand the concepts of clinical trial monitoring
Be able to identify the attributes of valid data and gain tools to review electronic and hard copy data to assess data integrity and fraud
Have tools to handle an FDA inspection

Note: Use coupon code 232082 and get 10% off on registration.
  • Deborah D. Linton Ph.D., DL Veterinary Consulting, LLC
    Dr. Linton has more than 20 years of experience in veterinary drug product development for both the US and EU. After completing degrees at Hanover College (B.A. mathematics) and Purdue University (M. S. and Ph.D., population genetics), she worked for veterinary pharmaceutical companies for 16 years at Cyanamid, Fort Dodge Animal Health, and Nexcyon Pharmaceuticals, Inc., where she held positions in clinical trial management, statistics, product development, and quality assurance. Prior to joining Nexcyon, she was a consultant in animal health development for 10 years and returned to consultancy work in 2014. She is active in the Society of Quality Assurance, and has spoken or trained on various quality assurance, clinical trial monitoring, data validity and compliance topics within veterinary drug development., United States

Kansas City

Kansas City, 64101, United States

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