ISO14155 Training
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|---|---|---|---|---|
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About this course
Reasons to attend
Join our ISO14155 training if you are a monitor, a project manager, or part of an investigator team and need to understand the counterpart of ICH-GCP for medical device trials. You want to know the rules and responsibilities outlined in ISO14155 and get some practical advice and tips on improving your medical device monitoring skills? This training is made for you and your colleagues!What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: One Day face-to-face training: 09h00-17h00 | Online: Webinars: 2 sessions of 3 hours |
Course Description
This training brings CRAs and Investigators up to speed with the ISO14155, when working with device clinical trials.This standard is mandatory in Pre-Marketing studies but is very frequently followed in the Post-Market release study environment, especially when the results of these trials are to be published in major medical journals. Although up to a certain level comparable to ICH-GCP, the ISO14155 standard features a series of requirements and terminologies that are very specific to medical devices.This ISO14155 training will guide the trainees through all the sections of this document.Programme highlight
- Focus on the overall content and structure of the ISO14155 standard
- In depth review of responsibilities of each of the medical device stakeholders
- Practical implementation of the standard
Learning objectives
- Understand the role of clinical studies in the development of devices
- Be familiar with the basic requirements for how clinical trials are carried out
- Appreciate the device-specific study elements as compared to drugs studies
- Be familiar the participants with expected clinical tasks
Who should attend
Project Managers, CRAs, study co-ordinators or Investigators working on Clinical Investigation with Medical Devices
Competencies
This ISO14155 training covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (4)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (0)
- Data Management and Informatics (4)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Jozef Tanczos
Miracor Medical
I am thankful for Marleen and Benedikt that have provided a very enriching experience not only for me but to all participants, through an interactive course and case based training, striving people to participate rather than just listening, and through the participation of an audience with mixed level of experience. The feedback I received from them was positive, considering the experience they have in the field and business. They confirmed the training session provided implementable knowledge for their day-to-day work, especially through the case-based workshops.
Vivian van Wegberg
Clinical Trial Center Maastricht
Lina Maria Zuleta Zamorano
Cryo Theurapeutics
Gert Everaert
Janssen
Anonymous