Challenges for project nurses in 2023

Learn how to handle the new legislation and optimise collaboration with sponsors in a busy work-day.

No available dates

On location

Danish

13,000 DKK ex VAT

(app. 1,748 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

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 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
    • Mia Ravn Jakobsen
      Lecturer
      Læge og Ph.d. studerende
      Rigshospitalet
    • Peter Eriksen
      Lecturer
      Lead Specialist, Safety Scientist
      H. Lundbeck A/S
    • Lene Palfelt
      Lecturer
      Competency Development Specialist
      Novo Nordisk A/S
    • Lotte Skoulund Laursen
      Lecturer
      Lægemiddelinspektør
      Lægemiddelstyrelsen
    • Birgitte Toxværd
      Lecturer
      Partner
      Kromann Reumert
    • Margit Joyce
      Lecturer
      Country Clinical Quality Manager, Nordic Baltic (CCQM NB)
      MSD Denmark ApS
    • Amalie Beckmann Runge
      Lecturer
      Jurist
      Rigshospitalet - Klinisk forskningsenhed
    • Stephanie Greer Hellowell
      Lecturer
      Jurist
      Rigshospitalet - Klinisk forskningsenhed
    • Pernille Tenggren
      Lecturer
      Jurist
      Rigshospitalet - Klinisk forskningsenhed
    See all

    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


    1. How is the new EUCTR Regulation to be interpreted and how is it put into practice?
    2. How are practical challenges with CETIS handled?
    3. Obligations as data controller and data processor.
    4. How do you ensure the patient's rights?

      What your company will get


      1. An employee who understands how the new EU Regulation should be interpreted and applied in daily work.
      2. An employee who are part of optimising the collaboration between sponsor and site.
      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 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
        Mia Ravn Jakobsen
        Læge og Ph.d. studerende
        Rigshospitalet
        Peter Eriksen
        Lead Specialist, Safety Scientist
        H. Lundbeck A/S
        Lene Palfelt
        Competency Development Specialist
        Novo Nordisk A/S
        Lotte Skoulund Laursen
        Lægemiddelinspektør
        Lægemiddelstyrelsen
        Birgitte Toxværd
        Partner
        Kromann Reumert
        Margit Joyce
        Country Clinical Quality Manager, Nordic Baltic (CCQM NB)
        MSD Denmark ApS
        Amalie Beckmann Runge
        Jurist
        Rigshospitalet - Klinisk forskningsenhed
        Stephanie Greer Hellowell
        Jurist
        Rigshospitalet - Klinisk forskningsenhed
        Pernille Tenggren
        Jurist
        Rigshospitalet - Klinisk forskningsenhed

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        Want to know more or need help?

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

        Send me a message