Practical Considerations for Conducting FDA-Required Regulated Studies

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

For Registration -   http://www.complianceonline.com/veterinary-drug-approvals-gmp-glp-vich-gcp-referesher-seminar-training-80267SEM-prdsm?channel=pickevent

Note: Use coupon code 232082 and get 10% off on registration.