GCP for Medical Devices Clinical Investigations
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This webinar covers the regulatory framework governing clinical investigations in the EU.
First of all we consider the Regulatory Environment for medical devices including the currently applicable Medical Device Directives and the changes coming in with the new Medical Devices Regulations which will apply in the next few years.
We then turn to Clinical Investigations with Medical Devices and their role in demonstrating Conformance for CE marking.
The main focus of the course is ISO14155, which provides guidance on Ethical Considerations, Planning and Management of Clinical Investigations and Roles and Responsibilities. There is also an overview of the changes anticipated with the forthcoming new version of ISO14155.
Who is it suitable for?
This webinar is suitable for those who need an introduction to GCP for clinical investigations, for example Project Managers, monitors, investigators, sponsors.
To provide delegates with an understanding of:
- The regulatory framework governing clinical investigations
- Overview of ISO14155.
- Changes coming to regulations and guidance on Medical Devices Clinical Investigations
- Medical Device Directives
- New Medical Devices Regulations
Clinical Investigations with Medical Devices
- Demonstrating Conformance
- When is a Investigation Required?
- Clinical Investigations with CE marked devices
- Ethics committee review
- Informed Consent
- Design and Statistical Considerations
- Risk Assessment
- Documentation required
- Management of the CI
- Quality Management
- Risk Based Monitoring
- Adverse Events and Device Deficiencies
- Data management
- Record keeping and retention
- CI Report
- Principal Investigator
New Version of ISO14155
- Key changes anticipated
Design of Medical Device Investigations: Special Considerations
- Blinding and Randomisation
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