Introduction to Clinical Research with Medical Devices

Tijdsduur
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Startdata en plaatsen

Brussels
21 okt. 2019

Beschrijving

Introduction to Clinical Research with Medical Devices

Course Description

This one day course is designed to introduce the fundamental concepts and regulatory requirements of clinical trials with medical devices. Topics include definition and classification of different types of medical devices, introduction to medical device regulations in Europe and in the US, the medical devices directive and the current ISO 14155 standard. Contents and requirements of the investigator's brochure and the investigational plan will be described. Participants will learn about the implementation of the latest directives and MEDDEVS, ruling the pathway of CE marking. In addition, an overview of the European re…

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Introduction to Clinical Research with Medical Devices

Course Description

This one day course is designed to introduce the fundamental concepts and regulatory requirements of clinical trials with medical devices. Topics include definition and classification of different types of medical devices, introduction to medical device regulations in Europe and in the US, the medical devices directive and the current ISO 14155 standard. Contents and requirements of the investigator's brochure and the investigational plan will be described. Participants will learn about the implementation of the latest directives and MEDDEVS, ruling the pathway of CE marking. In addition, an overview of the European requirements regarding safety
reporting will be presented.

Learning objectives

• To differentiate between various types of medical devices
• To understand CE marking
• To know about European and US medical device legislation
• To comprehend the ISO 14155 standard
• To identify documentation requirements specific to medical devices
• To have an overview of safety reporting in the European Union
• To recognize differences between drug and device development

Programme highlights

• Definitions and classification of medical devices
• Overview of European and US medical device regulatory requirements
• The ISO 14155 standard
• Safety reporting requirements in the European Union
• Differences between drug and device clinical trials

Who should attend

Everyone involved in clinical research and regulatory affairs in the medical device industry, including pharmaceutical and medical device companies, contract research organizations, investigators, site personnel. Anyone who requires an overview of the medical device sector

*Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or cancel the event.

Trainer: Mr. Stefan Hosten

Language: English

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