Speaker: Dr. Karolina Janikowska
This training, certified by Swissethics for both Investigator and Sponsor-Investigator level for clinical investigations with medical devices, fulfills the legal and regulatory requirements.
This training will enable you to link key regulatory and quality considerations when conducting clinical investigations on medical devices. The training is aimed at any employee involved in clinical activities who seek to enhance their knowledge and competences within this field.
ISO 14155 addresses 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 to protect the rights, safety, and well-being of the human subjects involved in the investigation. 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:
- Regulatory context
- General introduction to ISO 14155:2020
- Relation to ICH-GCP
- GCP core principles as defined in ISO 14155:2020
- Relation to GDPR
- Key changes introduced by ISO 14155:2020 (vs ISO 14155:2011) and how to transition
- Planning and design of clinical investigations
- Substantiation of safety and performance claims
- Value of an adequate Clinical Development Plan
- Statistical concepts
- Clinical investigation stages as depicted in ISO 14155:2020
- Roles and responsibilities of clinical investigation’s stakeholders
- Sponsor, principal investigator, Ethics Committee, Competent Authorities
- Essential documents throughout the clinical investigation
- Submission and authorization procedures
- Safety reporting including adverse event classification
- Monitoring activities
- Clinical quality management
- Handling of investigational medical device
- Study close-out
- Presentations with interactive discussions
- Group and individual exercises
- End of training assessment
To attend the course, you are expected to self-train on ISO 14155:2020 as well as Chapter VI of the MDR. You will be asked to complete an assessment related to clinical requirements of the MDR prior to the training. Any question related to the prerequisites may be addressed to the trainer.
EUR 760 incl. course material and certificate