Challenges for Project Nurses in 2024

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

Date icon

25 - 26 Apr 2024

Attendance icon

On location

Language icon

Danish

Price icon
13,000 DKK ex VAT

(app. 1,748 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

Save information for later
Read more

Course leader & lecturers

  • Hanne Storgaard Schultz
    Course leader
    Regional Director, Clinical Quality Management, EMEA
    MSD Danmark
  • Kasper Bendix Johnsen
    Lecturer
    Specialkonsulent, Cand.scient.med., ph.d.
    Nationalt Center for Etik
  • Ditte Zerlang Christensen
    Lecturer
    EU Project Manager
    Danish Medicines Agency
  • Pernille Ask Aabo
    Lecturer
    GCP Koordinator; M.Sc.Pharm
    GCP-enheden
  • Lene Palfelt
    Lecturer
    Competency Development Specialist
    Novo Nordisk A/S
  • Lotte Skoulund Laursen
    Lecturer
    Lægemiddelinspektør
    Lægemiddelstyrelsen
  • Stephanie Greer Hellowell
    Lecturer
    Jurist
    Rigshospitalet - Klinisk forskningsenhed
  • Amalie Beckmann Runge
    Lecturer
    Jurist
    Rigshospitalet - Klinisk forskningsenhed
  • Sara Goul Ærthøj
    Lecturer
    Director, advokat
    Kromann Reumert
  • Louise Saaby
    Lecturer
    Clinical Safety Professional
    Novo Nordisk A/S
  • Marianne Pilgaard
    Lecturer
    CEO
    Trial Nation
See all

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


  1. How to optimize 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 25 Apr 2024
      25 Apr 2024 9:00-16:00
      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
      26 Apr 2024 9:00-16:00
      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.

      Practical information

      Registration

      Registration deadline
      18 Apr 2024
      Atrium
      Lersø Parkallé 101
      2100 København Ø
      Register
      25 - 26 Apr
      Sometimes things change. This is the expected programme.

      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
      Regional Director, Clinical Quality Management, EMEA
      MSD Danmark

      Lecturers

      Kasper Bendix Johnsen
      Specialkonsulent, Cand.scient.med., ph.d.
      Nationalt Center for Etik
      Ditte Zerlang Christensen
      EU Project Manager
      Danish Medicines Agency
      Pernille Ask Aabo
      GCP Koordinator; M.Sc.Pharm
      GCP-enheden
      Lene Palfelt
      Competency Development Specialist
      Novo Nordisk A/S
      Lotte Skoulund Laursen
      Lægemiddelinspektør
      Lægemiddelstyrelsen
      Stephanie Greer Hellowell
      Jurist
      Rigshospitalet - Klinisk forskningsenhed
      Amalie Beckmann Runge
      Jurist
      Rigshospitalet - Klinisk forskningsenhed
      Sara Goul Ærthøj
      Director, advokat
      Kromann Reumert
      Louise Saaby
      Clinical Safety Professional
      Novo Nordisk A/S
      Marianne Pilgaard
      CEO
      Trial Nation

      You may also be interested in these courses

      Want to know more or need help?

      Contact Client Manager Christina Spangsberg at +45 39 15 09 22

      Send me a message