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    Trainings

    Curricular training for investigators and members of clinical investigation teams/groups

    CLINICAL INVESTIGATIONS
    This is an intensive training about all related matters regarding clinical research aspects with medical devices according to "Curriculare Fortbildungen für Prüfer und Mitglieder eines Prüfungsteams/einer Prüfergruppe" (Germany) (MDR/MPDG basic/advanced/refresher/update course for examiners and study teams).

    Topics of this session

    • Medical Device Regulation 2017/745 (MDR), MDCG-Documents, ISO 14155:2020, Declaration of Helsinki and other relevant regulations for Germany
    • Ethics Commission (EC), Competent Authority (CA)
    • Conduct of a Clinical Investigation, documentation, monitoring, and informed consent
    • Safety in clinical investigations, reporting obligations, corrective actions
    • Noncompliance, audits and inspections, frequent problems
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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

    Investigators, members of a clinical investigation teams/group, persons working in clinical research, safety reporting, regulatory affairs, quality management.

    After this session, you

    • can act as an investigator or in a clinical investigation team/group.
    • know the specific regulatory requirements for clinical evaluations with medical devices.
    • will learn relevant tasks during a clinical investigation.

    Notice

    This training is for beginners and advanced learners in this field.

    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.