Training objectives:
This training is organized into 2 modules with a duration of 3 hours each to provide participants with an extended understanding of the requirements introduced by ISO 14155:2020 – including a presentation of the practical aspects pertaining to the implementation of the new requirements to the procedures of your organization. The course will enable you to link key regulatory and quality considerations when conducting clinical investigations on medical devices. Furthermore, the linkage between the concepts of Good Clinical Practice (GCP) and the principles of the ISO 14155 standard will be outlined. This training is aimed at sponsors, investigators, clinical trial managers, clinical research coordinators, etc. involved in clinical activities who seek to enhance their knowledge and competencies within this field.
Training content:
ISO 14155 is addressing the design, conduct, recording, monitoring, and reporting of clinical investigations on medical devices and how to apply GCP when working with human subjects. The standard is established to ensure proper scientific conduct of clinical investigations, as well as protecting the rights, safety, and well-being of the human subjects included in the investigations. The principles of the standard should be applied to all types of clinical investigations intended to assess the clinical performance, effectiveness, and safety of medical devices. By attending this training, you will receive in-depth knowledge on the following topics:
- General introduction on ISO 14155:2020
- Key changes introduced by ISO 14155:2020
- Considerations regarding clinical study design
- Clinical investigation stages as depicted in the standard
- Understanding PMCF and its connection to clinical investigations
- GDPR compliance during study conduct
- Adverse event classification and reporting obligations
- Roles in the clinical investigation and their responsibilities
- Clinical quality management
- Handling of Investigational Medical Device