Summary
At this two 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 lecturers on the course include representatives from the public sector, the pharmaceutical sector, and the legal side in order to give you a comprehensive understanding and to illuminate all perspectives.
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
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Course leader & lecturers
- Hanne Storgaard SchultzCourse leaderRegional Director, Clinical Quality Management, EMEA
MSD Danmark
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Is this course for you?
This course is targeted at the experienced project nurse who wants to learn more about optimizing collaboration with sponsors, inspections, patient rights and much more...
What you will learn
- How to optimize the collaborations with sponsor.
- To understand inspections demand.
- Obligations as data controller and data processor.
- How to ensure the patient's rights.
What your company will get
- Higher quality and faster study management.
- Improved job satisfaction for the benefit of the patient.
- An employee who can apply GDPR rules in daily tasks.
- An employee who is equipped to ensure the patient's rights and who knows when to say yes and no.
Course calendar
Day 1
- Obligations as data controller and data processor
- Data transfers
- Common interpretation of GDPR in the regions (new guideline)
- Essential documents (discussion in plenary)
- Inspection findings and discussion of course participants’ submitted cases
- Bridging the public and the private sectors in clinical research
- Workshop – Cooperation between sponsor and site
Day 2
- Danish National Center for Ethics and DKMAs view on decentralized/hybrid clinical trials
- Workshop
- Discussion of course participants’ submitted cases
- The role of the safety expert
- Cases/Workshop
- The role of the project nurse in EU CTR
- Workshop
- based on submitted cases.
Registration
Registration deadline15 May 2025
Lersø Parkallé 101
2100 København Ø
Course information
Prerequisites
One month before the course starts, we ask you to send a case from your own daily tasks to Educational Programme Leader, Lone Rex at lrx@atriumcph.com. The case will be discussed at the course.
Course leader
MSD Danmark
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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