This Good Clinical Practice (GCP) course, certified by Swissethics for both Investigator and Sponsor-Investigator level for clinical investigation with medical devices, fulfils the legal and regulatory requirements.
Speaker: Dr. Jérôme Randall, Scientific Affairs Manager
Date: February 28th & 29th, 2024, Online
Duration: 6 hours | 2x 8:00 – 11:00 AM (EST), 3:00 – 6:00 PM (CET)
About the Speaker: Dr. Randall is a biochemist by education with extensive experience in neuroscience research. More recently, he obtained a Diploma of Advanced Studies (DAS) in Clinical Trial Management, Good Clinical Practice Implementation and Quality Processes from the University of Geneva. Throughout his career, he has acquired strong competence in clinical investigation, clinical trial applications, safety management, monitoring, data management, statistical analysis, and clinical quality processes according to ISO 14155:2020.
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 anyone involved in clinical activities seeking to enhance their knowledge and competencies in 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
- 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
- Clinical development stages
- Clinical investigation design
- Value of an adequate Clinical Development Plan
- Statistical concepts and considerations for sample size calculation
- 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
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment
- Participants will receive an ISO 14155:2020 – GCP training certificate upon successful completion of the end of training assessment
Prerequisite:
To attend the course, you are expected to self-train on Chapter VI and Annex XV of the MDR. You will be asked to complete an assessment related to the clinical requirements of the MDR prior to the training. Any questions related to the prerequisites will be addressed by the trainer.
Who Should Attend:
- Managers and employees working in Quality Assurance or Regulatory Affairs departments of medical device manufacturers
- Managers and employees working in Research and Development departments of medical device manufacturers
- Technical medical device consultants and associates
- Auditors of medical devices
Price:
EUR 625 including course material and certificate