Duration: 2 x 3 hours
Date: March 11th and 13th 2025, Online
Speaker: Dr Jérôme Randall

Training objectives:

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 person involved in clinical activities seeking to enhance their knowledge and competences within this field.

Training content:

ISO 14155 addresses the design, conduct, recording, monitoring, and reporting of clinical investigations on medical devices in accordance with the principles of good clinical practice (GCP) when working with human subjects. The standard is established to ensure proper scientific conduct of clinical investigations and integrity of the study results, as well as to protect the rights, safety, and well-being of the human subjects involved in the investigation. The standard should be applied to all types of clinical investigations intended to assess the clinical performance or 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
o Relation to ICH-GCP
o GCP core principles as defined in ISO 14155:2020
o Relation to GDPR
• Key changes introduced by ISO 14155:2020 (vs ISO 14155:2011) and how to transition
• Planning and design of clinical investigations
o Substantiation of safety and performance claims
o Clinical development stages
o Clinical investigation design
o Value of an adequate Clinical Development Plan
o Statistical concepts and considerations for sample size calculation
• Roles and responsibilities of clinical investigation’s stakeholders
o 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

Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment

Prerequisite:

To attend the course, you are expected to self-train Chapter VI of the MDR.