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Regulatory Essentials in Health Tech: Clinical Investigations in Practice

Startseite / Fortbildung und Termine / Regulatory Essentials in Health Tech: Clinical Investigations in Practice

Conducting a well-designed clinical investigation is undoubtedly the best way to produce information on the safety and performance of a medical device. Clinical investigations or studies can be demanding, and they often require several stakeholders from statisticians to health care professionals. Planning of clinical investigation should be part of the early development of a medical device to best comply with the requirements. Practical considerations related to the clinical investigation of medical devices are summarized in this session.

The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-DEMAND webinar sessions. Read more on the complete course page here >>

Inhalt

  • Identifying and verifying the need for a clinical investigation.
  • Defining the requirements and prerequisites for a clinical investigation.
  • Regulation (MDR), national law(s), and ISO 14155:2020 requirements.
  • Compiling and assessing a Clinical Investigation Plan (CIP).
  • Mandatory processes and documentation.
  • Needed approvals from authorities and preparation of applications.
  • Roles and responsibilities & facilities.
  • Budgeting and monitoring of a clinical investigation.
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Trainer

Hanna Marttila
Hanna Marttila
Senior Advisor, Clinical Studies
hanna.marttila@labquality.com

Hanna Marttila is the Senior Advisor for Clinical Studies in Labquality's CRO business. She has over 25 years of experience in the life sciences sector, both in the public and private sectors. Hanna has strong expertise in clinical studies (drugs and medical devices) in both commercial and academic settings, where she has held various roles. Her work experience in regulatory roles related to medical devices and in drafting international marketing authorization applications has given her a comprehensive understanding of business practices and the application of laws and regulations.

Zielgruppe

All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Clinical Investigations for medical devices. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

Nach diesem Training

  • Know the regulatory considerations on clinical investigations.
  • Are aware of the stages of a clinical investigation project.
  • Understand the necessary roles in clinical investigations.
  • Are aware of the approval practices related to clinical investigations.

Hinweis

This on-demand session is intended to provide a basic understanding of Clinical Investigation practices for medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4, session 8 for Risk Management, and session 11 for Clinical Evaluation before this on-demand session.

RECHNUNGS- UND STORNIERUNGSBEDINGUNGEN

Lesen Sie hier die Abrechnungs- und Stornierungsbedingungen für Online-Schulungen.

Die Teilnahme an der Schulung kann zwei Wochen (14 Tage) vor der Veranstaltung kostenfrei storniert werden. Bei Stornierungen, die danach erfolgen, berechnen wir 50 % der Teilnahmegebühr, bei Stornierungen, die eine Woche vor der Veranstaltung erfolgen, berechnen wir 100 % der Teilnahmegebühr.

Stornierungen erfolgen immer schriftlich an: koulutus@labquality.fi.  
Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@labquality.fi meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.

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