ISO 14155 GCP training

Learning objectives:

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. 

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.

Program 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.  

Costs

We offer open enrolment, on-location, train-the-trainer formats. Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.