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🇨🇿 Clinical research with medical devices and clinical trials according to MDR in hospitals

The webinar will focus on the topic of clinical trials from the perspective of healthcare providers. The issue of so-called other clinical trials under the MDR will be explained in detail and the related opportunities and limitations of clinical research on or with medical devices will be discussed.

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🇨🇿 Clinical research with medical devices and clinical trials according to MDR in hospitals
🇨🇿 Clinical research with medical devices and clinical trials according to MDR in hospitals

Date

12 Feb 2025, 13:00 – 15:30

Online: Cisco Webex

About

The event is held in Czech language only!


In the online seminar we will focus on the topic of clinical trials of medical devices from the perspective of hospitals. Healthcare providers play an important role in the clinical trial process for medical devices as defined in EU Regulation 2017/745 (MDR). It is important that providers know their obligations and limitations. However, often the role of healthcare providers is more fundamental as they are themselves involved in the validation of new treatments and, in this context, in the design and development of innovative medical devices. Sometimes this involves the use of a medical device outside its intended purpose, other times, for example, the design of a completely innovative medical device. Sometimes in collaboration with the manufacturer, sometimes as part of a grant solution that will result in a project report and publication. Therefore, in this seminar we will also focus in detail on the issue of so-called other clinical trials according to the MDR and explain the advantages and limitations of these trials. The seminar will provide an overview of the current legislative requirements and highlight the traps and dangers, such as conducting an illegal clinical trial.


Who the webinar is for:

  • project managers and professional staff responsible for clinical research projects and clinical trials at healthcare providers

  • physicians and all investigators of research projects at healthcare providers

  • doctors and nurses involved in clinical trials of medical devices

  • anyone wishing to conduct research involving the use of a medical device outside its intended purpose or the use of a medical device without CE marking

  • managers responsible for research

  • hospital lawyers responsible for contractual relations with sponsors of clinical trials

  • members of ethics committees

  • anyone wishing to become familiar with the specific field of clinical testing of medical devices and its differences from medicines development


Lecturers:

  • Aleš Martinovský

  • Kristýna Zobalová


Content:

  • legislative framework for clinical trials (EU MDR and national legislation)

  • other terminology: procedure, procedure and medical device, types of medical device use

  • medical device research and medical device use research, practical pitfalls

  • how to know when it is and is not a clinical trial

  • the roles of different natural and legal persons in the clinical trial process, including the role of the sponsor and the role of the investigator

  • the specific position of the ethics committee and the role of the State Institute for Drug Control

  • details of the clinical trial initiated by the sponsor of the clinical trial pursuant to Article 62(1) of the MDR

  • detail on another clinical trial pursuant to Article 82 of the MDR

  • answers to questions from practitioners


Additional information:

  • during the webinar, participants will have the opportunity to ask questions

  • each participant will receive a certificate of participation

  • a PDF presentation will be sent to all participants


Participation fee:

  • 3.900 CZK excluding VAT

  • 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant


Webinar hosted by:

  • Porta Medica

  • ID: 03301931, VAT: CZ03301931

  • registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město

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