About the Speaker: With more than ten years of post-PhD experience and a strong publication record, Olivier is a highly qualified neuroscientist. He holds 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, Olivier has provided clinical and scientific services for a diverse range of Medical and In Vitro Diagnostic devices used to treat a multitude of pathologies. He has a strong experience in Clinical Evaluation of Medical Devices ranging from implantable to software devices, and from class I to III. This complements his other area of specialty related to Clinical Investigations, which includes clinical study design, statistical activities, writing and management of Clinical Trial Applications, and planning of PMCF activities. For the last two years, Olivier has been providing statistical support across for a variety of projects, and is responsible of the biostatistics and clinical data analysis at Veranex Switzerland SA.
This Good Clinical Practice (GCP) course, certified by Swissethics, fulfills the legal and regulatory requirements for both Investigator and Sponsor-Investigator level for clinical investigations of medical devices.
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.
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