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🇨🇿 Clinical trial and PMCF trial in practice

The webinar is intended for medical device manufacturers who need to obtain sufficient clinical evidence for a clinical trial or an update. The seminar is also intended for anyone developing a new medical device who finds clinical trials an organisational and financial barrier difficult to overcome.

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🇨🇿 Clinical trial and PMCF trial in practice
🇨🇿 Clinical trial and PMCF trial in practice

Date

13 Feb 2025, 09:30 – 12:00

Online: Cisco Webex

About

The event is held in Czech language only!


In this seminar, we will provide valuable practical information to anyone considering, planning or preparing a clinical trial, or needing to complete clinical data on their device in the form of a PMCF trial. The aim of the seminar is to clarify the responsibilities of the sponsor of a clinical trial. The workshop will provide a "cookbook" on not only how to address the various step-by-step requirements, but also how to properly plan and manage expectations regarding the cost and time required to conduct a clinical trial. We will also look into the necessary documentation to clarify the structure of the documentation, its quality and the level of expertise required for successful implementation of the plan. The seminar will also cover how to proceed when the sponsor encounters a problem with the (non-)existence of an ethics committee, when it is necessary to report a PMCF trial to the State Institute for Drug Control and other topics. We will introduce you to the main parts of the clinical trial plan according to EN ISO 14155 and the structure of all necessary documentation. For those considering other ways of obtaining clinical data, we will briefly outline in the last part of the seminar how else clinical data can be obtained, or when and how to base a clinical trial on non-clinical data. And we will explain the practical limitations and disadvantages of these alternative approaches.


Who the webinar is for:

  • medical device manufacturers who need clinical data for the clinical evaluation of a newly marketed device

  • medical device manufacturers who lack clinically and commercially actionable data on the clinical benefit of their device

  • medical device manufacturers wishing to ensure compliance of their devices with current regulatory requirements

  • personnel responsible for the clinical evaluation of devices,

  • researchers, designers and programmers who want to understand the process of obtaining clinical data through a clinical trial

  • healthcare providers with responsibility for clinical trials and research and anyone working in the healthcare sector who wants to understand the

    clinical trial process, PMCF trials and the importance of post-market PMCF trials

  • anyone who is preparing a clinical trial or PMCF trial and needs to know the MDR requirements and current practice


Lecturers:

  • Magdalena Folkmanová

  • Aleš Martinovský


Content:

  • introduction of types of clinical trials according to MDR and their specifics

  • basic roles in the clinical trial process and their responsibilities

  • process and preparation - how to plan everything practically and commercially

  • what precedes a clinical trial

  • briefly on the hypothesis to be tested

  • the role and approval of the ethics committee

  • reporting and approval of the clinical trial by the State Institute for Drug Control

  • the legislative anchorage of CSN EN ISO 14155

  • clinical trial plan and annexes

  • specifics of PMCF trials in detail

  • how a clinical trial can be avoided

  • specifics of clinical trials without clinical data

  • answers to questions from practice


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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