Conducting Medical Device Clinical Investigations in Switzerland
This course provides a comprehensive overview of the regulatory and ethics requirements in Switzerland when conducting clinical investigations with medical devices in the pre-and post-market phase including:
- Who are the players at the Competent Authority (Swissmedic) and Ethics Committees?
- What are the laws concerning medical devices and clinical investigations with medical devices, including multiple references to the applicable guidance documents and templates/forms to be used?
- What are the notification requirements of Swissmedic?
- What are the notification requirements to the Ethics Committees?
- Safety reporting requirements during the clinical investigation
- Other reporting requirements during the clinical investigation and at close-out
- What are the clinical trial insurance requirements?
- What are the data protection requirements?
Upon completion of this course, trainees will be able to correctly and successfully:
- Compile clinical investigation notification to Swissmedic
- Compile clinical investigation submission to any Swiss Ethics committees
- Set up a compliant reporting system during clinical investigations both to Swissmedic and to the Ethics Committees in Switzerland
- Perform reporting to Swissmedic and Ethics Committees in Switzerland at close-out of a clinical investigation
- Ensure compliance with any additional requirements, such as clinical trial insurance and data protection in Switzerland during a clinical investigation
Principal and co-investigators, study coordinators, site managers, and other hospital or ancillary staff involved in medical device clinical investigations. Clinical Research Associates, Sponsor’s clinical trial coordinators, Clinical Research Project Managers, Clinical Directors and Regulatory managers involved in submissions and conduct of clinical investigations in Switzerland
Understand the general requirements for the conduct of a clinical investigation as outlined either in the suite “Medical Device GCP for Investigators” (ID 187) and/or the “Effective Monitoring” suite of courses (ID 57) with in addition the requirements of ISO 14155 as outlined in the suite of courses “ISO 14155:2011 In Depth Review” (ID 68)