Summary

At this 2-day course, we review and discuss current cases, and you learn how to interpret and deal with the authority requirements and cooperation with sponsor.

• What is right and wrong?
• What are the interfaces between sponsor and site?
• What are the patient’s rights?

The Danish Medicines Agency presents a selection of the inspection findings they have encountered and explains how a site can improve. In addition, the practical consequences of sponsor oversight for sites are highlighted and discussed, including how collaboration can become even better.

There will also be a focus on the ethical perspective: what is the role of the patients? And what are their rights? An important element of this is data handling, and we clarify who is legally responsible.

All in all, a focused, academically intense, and practically oriented course, which puts your day-to-day challenges at the centre.

To strengthen the discussions and ensure that you take home practical knowledge, we ask you to send us a case from your everyday life that you want to be taken up during the course.

Show up, listen, learn, discuss, and make the pieces of your everyday challenges fall into place.

Other course participants say

"The course was highly relevant to the practice of a project nurse. The topics were well chosen and the participants were quite experienced, which I apppreciated. An excellent course venue and the panel were skilled and great communicators."

Therese Gents, Head Nurse, Region Syddanmark

"Great presentations as well as relevant discussions and feedback. All questions submitted were answered."

Jannie Kirkegaard, Project Nurse, Region Syddanmark

Keywords

• Collaboration between sponsor and site
  
• Inspections
• Patients' rights
• Data security
• EU CTR