Clinical Trial Inspections: Preparing for a good outcome
Course description
This course is designed to provide a basic understanding of the inspection process - under special consideration of FDA inspections - in clinical drug development and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome.
An overview of the inspection process in a Good Clinical Practice environment will be presented.
Inspections are a fact of life when running clinical trials. This course will provide delegates with:
- Information about how inspections are conducted
- Advice on preparing for inspections and providing information to inspectors
- Summary of common inspection findings
- Advice on responding to inspection findings
Learning objectives:
- Understand how inspections are conducted
- Get hands on information about how to prepare the team and documentation for a smooth inspection
- Get an overview of applicable inspection standards
- Know the data and document requirements specific to inspections
- Know how to prepare for sponsor/CRO and sites inspections
- Recognise continuous high quality standards as a method of ensuring data quality
Programme Highlights
- Assign the right persons for the inspection stage and support
- Prepare the documentation¨
- Prepare the team
- How to present non-compliances occured during trial conduct
- Technical hints and right behaviour
Who should attend
The course is developed for all staff who may be involved during an inspection, such as clinical operations staff, CRAs, project managers, investigators and their staff.
*Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or cancel the event.
Trainer: Marleen Verbeeck, PhD & Gerald Van Roey
Important: In case you have more than 5 interested participants you can save about 50% of your costs by inviting the trainer over for a tailored on-site training
