ISO 14155 Training GCP - Sponsor and Investigator-initiated Trials

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-initiated trials (IIT), on a regular basis.

During this one-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.

Learning goals

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 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. 

Focus points:

Patient safety; Data quality; Practical approach; Good documentation practice; Site selection, communication, and collaboration; Clinical strategy.

For whom: 

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.

Course overview: 

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

Experience

Our trainers have gained broad experience with ISO14155/GCP in practical settings as CRA, clinical trial manager, notified body reviewer etc. What are your responsibilities as a sponsor? How to implement good documentation practices? Is monitoring necessary and to which extent? Data handling in a practical and compliant way. All aspects of the standard will be discussed.

We can provide a training on location for your whole team, as well as at our office or in an online format.  

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