Good Clinical Practice
In the development of a veterinary medicinal product, clinical trials in the target species follow non-clinical studies. This seminar covers the principles of Good Clinical Practice (GCP) and explains how clinical trials are planned, conducted, monitored and documented.
Seminar content
- VICH-GCP: principles and regulatory framework
- Distinguishing GLP from GCP
- Planning and conduct of a clinical trial
- Study protocol and trial documentation
- Responsibilities of the sponsor and investigator veterinarian
- Handling of the investigational veterinary product and study animals
- Monitoring and data quality
- Audits and regulatory inspections
- Final Study Report
Clinical trials under VICH-GCP
Clinical trials provide important data on the efficacy and safety of a veterinary medicinal product under conditions of use. VICH-GCP sets international quality standards for this work, with particular emphasis on a clear study protocol, reliable data, defined responsibilities and the welfare of study animals.
This seminar gives you a practical overview of the full lifecycle of a GCP-compliant clinical trial, from planning through monitoring and documentation to the final study report. You will also learn about the roles and responsibilities of the people and organisations involved.