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    Trainings

    Publication of clinical study data

    MEDICAL DEVICES

    A one-day intensive training about all related matters regarding the preparation of a scientific publication including a workshop.

    Topics of this session

    • What is a publication, reasons and goals, regulatory requirements, different forms of publication, target groups
    • Research before publishing, journal selection, requirements for authors, literature research, data selection, quality control, dealing with negative data and inconsistent results, merging data from multiple studies, criteria and checklists, CONSORT, further standards, criteria and checklists
    • Minimum standards for scientific publications, the writing process, correct formulation, target group orientation
    • Publication as a marketing tool, regulations to be observed, advertising ban and special cases, problematic statements, practical problems with scientific publications, cost/benefits considerations
    • Workshops: Consideration of the publication already in the study planning, decision on the publication of the results, application of the CONSORT criterion
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    Trainers

    Kirsten Sander
    Kirsten Sander
    ARTIMED, Clinical Research Team Lead
    kirsten.sander@aurevia.com
    Kirsten Sander, MSc Biology, is the Clinical Research Team Lead for Labquality’s subsidiary Artimed Medical Consulting GmbH in Germany. She has been working in clinical research for more than 10 years, with experience in medical and scientific writing, monitoring, and project management. She has in-depth knowledge of regulatory requirements for clinical investigations (EU MDR, MDCG, ISO 14155, German MPDG), clinical evaluations, and post-market clinical follow-ups.

    Target group

    People working in clinical research, safety reporting, regulatory affairs, and quality management.

    After this session, you

    • you are familiar with the specific requirements for publications about medical devices
    • you are aware of the different options which exist in this context and how to select the right scientific journal
    • you know which writing techniques are expected
    • you can deal with the peer-review process until reaching acceptance of the publication
    • you will be able to prepare a scientific publication taking into account the requirements for the specific medical device

    What next?

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    Billing and cancellation policy

    Read the billing and cancellation policy for online trainings here.

    Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

    Cancellations are always made in writing to: koulutus@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@aurevia.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.