Challenges for Project Nurses in 2027

Get wiser on how to optimise cooperation with sponsors, handling of inspection requirements and ethical issues in a busy everyday life.

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10 - 11 Jun 2027

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On location

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Danish

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13,000 DKK ex VAT
50% discount for public institutions i
You cannot combine different discounts and offers. See our terms and conditions for more information.

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

"It's a course that refreshes and deepens your understanding of the many complex issues you face in your daily work life. I strongly recommend it."


"Well-structured course with a good variation of knowledge-sharing formats. Excellent speakers overall. The service at Atrium was outstanding - I felt spoiled both professionally and personally. Thank you for that."

Julie Palmer, Forskningskoordinator, Rigshospitalet


"Really great course. A professional vitamin boost for everyday work."

Christel Nielsen, Projektsygeplejerske


Keywords

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

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Course leader & lecturers

  • Hanne Storgaard Schultz
    Course leader
    Director, Clinical Quality Operations Lead
    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 optimising collaboration with sponsors, inspections, patient rights and much more...

What you will learn


  1. How to optimise the collaborations with sponsor.
  2. To understand inspections demand.
  3. Obligations as data controller and data processor.
  4. How to ensure the patient's rights.

    What your company will get


    1. Higher quality and faster study management.
    2. Improved job satisfaction for the benefit of the patient.
    3. An employee who can apply GDPR rules in daily tasks.
    4. An employee who is equipped to ensure the patient's rights and who knows when to say yes and no.



    Course calendar

    Starting 10 Jun 2027
    10 Jun 2027 8:45-16:30
    Day 1
    • Obligations as data controller and data processor
    • Data transfers
    • ICH E6 (R3)
    • Essential records
    • GCP inspection findings
    • Networking
    11 Jun 2027 9:00-16:00
    Day 2
    • Collaboration between Danish National Center for Ethics, The Danish Medicines Agency, and project nurses
    • Workshop - Handling of GCP tasks (sponsor/site)
    • The roles and responsibilities of investigator and sponsor
      • Workshop - Based on submitted cases
      Practical information

      Registration

      Registration deadline
      3 Jun 2027
      Atrium
      Lersø Parkallé 101
      2100 København Ø
      Price
      13,000 DKK
      Register
      10 - 11 Jun
      Please note: The programme structure may be subject to minor adjustments

      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

      Hanne Storgaard Schultz
      Director, Clinical Quality Operations Lead
      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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