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 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 the new regulation and CTIS fall into place
Keywords
- EUCTR Regulation
- CTIS
- GDPR
- Sponsor
- Site
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Course leader & lecturers
- Hanne Storgaard SchultzCourse leaderRegional Director, Clinical Quality Management, EMEA
MSD Danmark
Is this course for you?
This course is targeted at the experienced project nurse who wants to understand CTIS and the new EU Regulation 31012022 and learn how to use them in daily tasks.
What you will learn
- How is the new EUCTR Regulation to be interpreted and how is it put into practice?
- How are practical challenges with CETIS handled?
- Obligations as data controller and data processor.
- How do you ensure the patient's rights
What your company will get
- An employee who understands how the new EU Regulation should be interpreted and applied in daily work.
- An employee who are part of optimising the collaboration between sponsor and site.
- 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
The patient's role
- Ethical rules
- What are the patient's rights in relation to data access, and who may have access to data?
How can collaboration between sponsor and site become even better?
Discussion of cases
Day 2
GDPR:
- Obligations as data controller and data processor
- Data transfers
GCP:
- CTIS and new EU Regulation 30012022
- Inspection findings
- Sponsor oversight: practical consequences for the site
- Source data: possibilities and limitations
Discussion of course participants’ own cases
Registration
Registration deadline18 Apr 2024
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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