This two-day course will provide a comprehensive overview and suggest practical approaches to the design, set-up and conduct of veterinary clinical trials in compliance with VICH good clinical practice (GCP) principles and other regulatory guidelines.
The programme will address the responsibilities of all study roles, required documentation, data handling processes and statistical analysis. Sessions will also explore the appropriate quality standards to be applied to warrant data that is acceptable to regulators in the EU and USA.
Delegates will be expected to work through solutions to a number of challenging case studies which will help consolidate learning. There will also be ample opportunity for discussion with the expert faculty who all have considerable experience in this field.
Benefits of attending:
- Understand the regulatory requirements and study design
- Know how to compile compliant protocols
- Take away practical advice on how to set up clinical studies
- Learn how to practically conduct and manage compliant clinical studies
- Clarify specific aspects of clinical studies
- Gain a better understanding of data and ‘appropriate’ statistics
- Discover how to produce a compliant final study report (FSR)
- Assure the quality of clinical studies
Comments are closed.