Challenges for project nurses in 2023

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

1 - 2 Jun 2023

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

    Key words

    • EUCTR Regulation
    • CTIS
    • GDPR
    • Sponsor
    • Site

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    Course leader(s) & Lecturer(s)

    • Hanne Storgaard Schultz
      Course leader
      Regional Director, Clinical Quality Management, EMEA
      MSD Danmark
    • Birgitte Toxværd
      Lecturer
      Partner
      Horten Advokatpartnerselskab
    • Kasper Bendix Johnsen
      Lecturer
      Akademisk medarbejder i De Videnskabsetiske Medicinske Komitéer
      Sundhedsministeriet
    • Mia Ravn Jakobsen
      Lecturer
      Læge og Ph.d. studerende
      Rigshospitalet
    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 calendar

        Starting 1 Jun 2023
        1 Jun 2023 9:00-16:00

        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

        2 Jun 2023 9:00-16:00

        DAG 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


        Practical information

        Registration

        Registration deadline
        25 May 2023
        Atrium
        Lersø Parkallé 101
        2100 København Ø
        Register
        1 - 2 Jun
        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(s)

        Hanne Storgaard Schultz
        Regional Director, Clinical Quality Management, EMEA
        MSD Danmark

        Lecturer(s)

        Birgitte Toxværd
        Partner
        Horten Advokatpartnerselskab
        Kasper Bendix Johnsen
        Akademisk medarbejder i De Videnskabsetiske Medicinske Komitéer
        Sundhedsministeriet
        Mia Ravn Jakobsen
        Læge og Ph.d. studerende
        Rigshospitalet

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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