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.
Upon completing this course participants should:
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:
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.
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