Date: 13 &14 April 2021
Time: 09.00 until 13.30 CEST time zone (both days)
Costs: € 1350,-
Qserve Medical Device CRO and consultancy offers you a hands-on GCP course that supports your everyday clinical operations and quality issues. Our course is set up especially for professionals in the medical device industry that work on clinical trials, PMCF studies and investigator initiate trials (IIT), on a regular basis.
During this 2-day course, the content of the ISO-14155 GCP standard for medical devices will be our guide. During the interactive sessions, we will discuss the practical implementation of the standard. The theory will be supported by real live examples of difficulties and mistakes on the one hand, but also practical and clever solutions that avoid unnecessary bureaucratic burdens on the other hand. At the end of the day, you will go home with knowledge, GCP skills and practical ideas to implement directly within your organization, and you will receive your personal GCP certificate.
NEW! We will also take the opportunity to inform you and discuss the key changes in the new 2020 version of the standard.
Note: this training can also be provided in-house for other organizations in the supply chain involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing or provision of associated activities. The contents will be adapted to the specific role(s) of that organization.
- To understand the content and role of the ISO-14155 standard in clinical investigation
- To be able to implement the standard in a practical way during the preparation, execution and evaluation of clinical studies with medical devices
- To learn from real life examples that we come across in our everyday CRO and consultancy practice.
- Allowing you an exclusive look behind the scenes of several example trials.
- Patient safety
- Data quality
- Practical approach
- Good documentation practice
- Site selection
- Communication and collaboration
- Clinical strategy
Typical clinical investigation terminology and GCP definitions
Differences and similarities between ISO-14155 for Medical devices, and other GCP standards (e.g. ICH-GCP)
Key changes in the upcoming ISO 14155-2020
Review and discuss the content of ISO 14155 (2011)
Investigator-initiated studies: compliance and value
Practical clinical investigation planning and execution, including real-world examples
Commonly seen pitfalls and how you can avoid them in your trials
Questionnaire and answers
Who should attend this course?
Clinical and regulatory personnel working at a medical device manufacturer, who are involved in the preparation, execution or evaluation of clinical investigations with medical devices.
Personal GCP certificate.