Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies: One and a Half day In-Person Seminar

By: Deborah D. Linton, Ph.D., DL Veterinary Consulting, LLC
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Course “Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies” has been pre-approved by RAPS as eligible for up to 10 credits towards a participant’s RAC recertification upon full completion.

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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

Who Will Benefit:

This course is designed for people wanting to learn the core concepts of veterinary drug studies required for regulatory approvals. Emphasis will be placed on veterinary clinical trials, including protocols, monitoring, data review, and quality assurance. Target animal safety studies, GLPs, and procedures for FDA inspections will also be discussed. Following personnel will benefit from the course:

  • Individuals involved in academia interested in veterinary trials
  • Human pharmaceutical professionals interested in veterinary trials
  • Veterinarians interested in regulated research
  • Clinical trial managers
  • Product development professionals
  • Quality assurance professionals
  • Regulatory professionals
  • Professionals seeking VICH GCP refresher training
  • Contract research organization personnel

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  1. Course Objectives
  2. VICH and VICH Good Clinical Practice (GCP) (VICH GL9)
    1. History of VICH
    2. VICH GCP Objectives
    3. GCP Concepts
      1. Personnel Roles and Duties
      2. Facilities
      3. Standard Operating Procedures (SOPs)
      4. Protocols and Data Forms
      5. Investigational Veterinary Product (IVP)
      6. Study File
      7. Final Study Report (FSR) and FSR Amendments
      8. Document Submission to FDA and Archiving
  3. GCP vs. GLP
    1. Key Areas and Differences
    2. Which to Use
    3. US GLP vs. OECD GLP
    4. Implementing GLPs
  4. Target Animal Safety(TAS) Studies (VICH GL43)
    1. What are TAS Studies?
    2. Regulations
    3. Margin of Safety Study
    4. Other Safety Studies
    5. Reproductive Safety
  5. More on Protocols
    1. Definitions in Regulations
    2. Protocol Components
    3. Control of Bias
      1. Randomization and Blocking
      2. Masking
      3. Comparator(s)
      4. Sampling Plan
    4. Statistical Plan
    5. Changes to Protocol
    6. Protocol Tips
  6. Quality Assurance Unit and VICH GCP Quality Procedures
    1. VICH GCP References to QA
    2. Quality Assurance Unit (QAU) Definition
    3. QAU vs. Quality Control
    4. Beyond QC
    5. Advantages of QAU for GCPs
    6. Implementing a QAU
    7. Evaluating a QAU
Day Two (8:30 AM – 12:00 PM)
  1. Monitoring Animal GCP Trials
    1. Duties of a Monitor
    2. Phases to Monitor
    3. Remote Monitoring
    4. Monitor Training and Mentoring
    5. Contract Research Organizations
    6. A Monitoring Example
  2. Valid Data and Data Integrity
    1. Attributes of Valid Data (ALCOA)
    2. How to Correct Paper Data
    3. Common Paper Data Problems
    4. Common Data Problems
    5. A Data Exercise
    6. Good Data Collection Habits
    7. Data Concepts
  3. Managing FDA GCP Inspections
    1. For the Inspection Coordinator
    2. For the Investigator
    3. Before the Inspection
    4. Inspection Room
    5. Role of the Inspection Coordinator
    6. Documents
    7. The Inspection Process
    8. 483 Response
    9. Questions that May Occur
    10. General Issues that Can Arise
  4. Putting it to Work
    1. Summary
    2. Role of Regulator
    3. Non-Compliance
    4. Going Forward
  5. Questions

Meet Your Instructor

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.

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