Regulatory Essentials in Health Tech – Session 12: Clinical Investigations in Practice


Conducting a well-designed clinical investigation is undoubtedly the best way to produce information on 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 clinical investigation of medical devices are summarized in this session.

The Regulatory Essentials in Health Tech training series consists of fourteen 2,5h webinar sessions.
Read more on the complete course page here.


 

SPRING 2022
Time: 10.5.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 6.10.2022
Place: Online
Price: 250€ + VAT 24%

 

Target Group:
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.

After this session, you:

  • 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

Notice:
This session is intended to provide the basic understanding on Clinical Investigation practices for medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4 as well as the sessions 8 for Risk Management and 11 for Clinical Evaluation prior to this course.

Trainer:

Hanna Marttila

Hanna:
I hold more than 25 years experience within heavily regulated life science business both in public and private sector. I have strong expertise in clinical trials (drugs and medical devices) both in commercial and academic settings in various positions. My working experience in medical device regulatory affairs with worldwide submissions and sales approvals has given me deep understanding of business practices, laws and regulations.

CONTENT OF THIS SESSION:

    • Identifying and verifying the need of 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 & preparation of applications
    • Roles and responsibilities & facilities
    • Budgeting and monitoring of a clinical investigation

BILLING AND CANCELLATION POLICY 
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@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. 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.

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