Conducting Medical Device Clinical Investigations in Switzerland
Course Description:
This course provides a comprehensive overview of the Swiss regulatory and ethical requirements for conducting clinical investigations with medical devices in the pre-and post-market phases.
This course covers the following topics:
- Members of the Swiss Competent Authority (Swissmedic) and Swiss Ethics Committees
- Laws concerning medical devices and clinical investigations with medical devices, including references to the applicable guidance documents, templates, and forms
- Notification requirements of Swissmedic and Swiss Ethics Committees
- Safety reporting requirements during clinical investigations
- Other reporting requirements during clinical investigations and close-outs
- Clinical trial insurance requirements
- Data protection requirements
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Compile clinical investigation notifications to Swissmedic and Swiss Ethics Committees
- Set up a compliant reporting system during clinical investigations
- Report to Swissmedic and Swiss Ethics Committees after clinical investigation close-outs
- Ensure compliance with any additional requirements during clinical investigations, such as clinical trial insurance and data protection
Who Should Enroll:
Principal and co-investigators, study coordinators, site managers, hospital or ancillary staff involved in medical device clinical investigations, clinical research associates and project managers, sponsors, clinical trial coordinators, and directors and regulatory managers involved in submissions and conduct of clinical investigations in Switzerland are all encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- Medical Device GCP for Investigators (series; IDs 193, 200, 212, 202, 204, 206)
- Effective Monitoring of Medical Device Clinical Investigations (series; IDs 41–48, 59, 56, 50–55, 108, 96)
- ISO 14155: In-Depth Review (series; IDs 61–67)