Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies 2015 is a course that covers topics such as:
- The similarities and differences between GCP and GLP and their application to trial types
- The concepts of VICH GCP
- Target Animal Safety studies and the structure and requirements of margin of safety studies
- How GLPs can be implemented
- The differences between quality audit procedures and quality assurance procedures
- How to write good clinical trials protocols
- Identify the attributes of valid data and gain tools to review electronic and hard copy data to assess data integrity and fraud
- The concepts of clinical trial monitoring
- How to handle an FDA inspection
Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies 2015 brings together:
- Human pharmaceutical professionals interested in veterinary trials
- Individuals involved in academia interested in veterinary trials
- Clinical trial managers
- Veterinarians interested in regulated research
- Quality assurance professionals
- Product development professionals
- Professionals seeking VICH GCP refresher training
- Regulatory professionals
- Contract research organization personnel
