🇨🇿 How to avoid clinical trials?

This event is held in Czech language only!

About the event:

Conducting clinical trials is a nightmare for all manufacturers and designers of innovative medical devices. Many wonder how they could avoid clinical trials. Usually for economic reasons, but often for reasons of time and organization as well. In the context of placing a medical device on the EU market, this is of course a legitimate consideration, especially when we take into account that the device in question has no commercial history and its commercial potential is still being estimated. All these considerations should be reflected in a document called the Clinical Investigation Plan. However, in the case of innovative devices, it can be said with some exaggeration that clinical trials are a "fair punishment for innovation."

In this webinar, we will address all aspects that need to be taken into account when planning a clinical trial. It is possible that a clinical trial will be the only way to obtain relevant clinical data for assessing safety and efficacy. However, it is also possible that conducting a clinical trial will not be necessary. But is it also the most appropriate strategy from a regulatory and commercial point of view? We will discuss these and similar considerations at a seminar with the deliberately provocative title "How to avoid a clinical trial." The aim of the webinar is to provide a comprehensive regulatory and commercial perspective on the planning of clinical trials and to identify and discuss the parameters that need to be considered when deciding whether or not to conduct a clinical trial.

Who the webinar is for:

• Manufacturers of medical devices and their accessories

• Manufacturers of devices without therapeutic purpose according to Annex XVI of the MDR

• R&D organizations (spin-offs, start-ups) in the field of medical devices

• Innovators and researchers in the field of biosciences

• Doctors involved in clinical evaluations and clinical trials of medical devices

• Clinical evaluation experts from notified bodies

• Anyone who works or plans to work in the field of clinical evaluation of medical devices

Lecturers:

• Aleš Martinovský

• Magdalena Folkmanová

Content:

• What is a clinical trial and why (not) to avoid it

• Clinical evaluation plan and other basic terms

• Sources of clinical evidence for clinical evaluation

• Mandatory clinical trials – when and why

• Specifics of devices without therapeutic purpose according to Annex XVI

• Types of trials according to Articles 62, 74, and 82 of the MDR

• Brief overview of the process of notification and conduct of a clinical trial

• Time, costs, statistics, and other considerations

• Demonstration of compliance with safety and performance requirements based solely on preclinical evaluation/non-clinical testing methods (Article 61 (10))

• Lack of clinical evidence, unacceptable benefit-risk ratio, and other critical moments in the conformity assessment process

• Clinical evaluation and marketing of medical devices

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 s.r.o.

• ID: 03301931, VAT: CZ03301931

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