Date: 19 & 20 June 2019
Location: Amsterdam, the Netherlands
Price: Regular € 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 practical implementation of the standard. 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.
- To understand the content and role of the ISO-14155 standard in clinical investigations.
- 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.
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.
After getting to know each other a bit more while enjoying a coffee or tea, we will discuss:
- Typical clinical investigation terminology and GCP definitions
- Differences and similarities between ISO-14155 for Medical devices, and other GCP standards (e.g. ICH-GCP)
- Review and discuss the content of ISO-14155 (2011):
- Ethical considerations
- Clinical investigation planning
- Clinical investigation conduct
- Suspension, termination, and close-out of clinical investigations
- Sponsor responsibilities
- Investigator responsibilities
- 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
Personal GCP certificate.