2021-12-16 2022-03-17 , Online Online, 1.390,- € zzgl. MwSt. Dr. med. Markus Hahn https://www.forum-institut.de/seminar/22032500-multinational-clinical-trials-of-medical-devices/referenten/22/22_03/22032500-online-course-multinational-clinical-trials-of-medical-devices_hahn-markus.jpg Multinational Clinical Trials of Medical Devices

Learn how to effectively organise multinational clinical trials for medical devices in the US, Europe and China in accordance with the international standard (ISO 14155).

Topics
  • Multinational clinical trials: before, during and at the end of the study
  • The regulatory framework for clinical trials in the US, Europe and China
  • International standard ISO 14155: Clinical investigation of medical devices for human subjects - good clinical practice
  • Country selection for multinational clinical trials
Aims and objectives
To access foreign markets, medical device companies need to perform clinical trials in the respective countries. From an organisational and economic point of view, it is useful to choose a concerted multinational and multicentre trial set-up.

However, multinational clinical trials are more time consuming and need more preparation, documentation and evaluation. ISO 14155 is an international standard for clinical investigations of medical devices.

In this course, you will learn about the efficient planning, implementation and termination of a multinational clinical trial in compliance with inconsistent regulatory requirements. Our experts feel right at home in the regulatory world and will show you the pitfalls and stumbling blocks of clinical investigations.
Who should attend

This online course addresses the needs of employees in the medical device industry and contract research organisations (CROs), in particular those who organise, accompany, implement and monitor international clinical trials of medical devices.

Online Course Multinational Clinical Trials of Medical Devices

Multinational Clinical Trials
of Medical Devices

The efficient planning, implementation and termination of a
multinational clinical trial in the US, Europe and China

Benefits
  • Meet the experts!
  • The essentials in two days!
  • Online format: modern, flexible, interactive
  • We are following the IMI qualitiy criteria

Webcode 22032500

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Referenten


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Termin

16. - 17.03.2022

16. - 17.03.2022

Zeitraum

Day 1: 14:00 - 17:00Day 2: 10:00 - 1...

Day 1: 14:00 - 17:00
Day 2: 10:00 - 17:00
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

Learn how to effectively organise multinational clinical trials for medical devices in the US, Europe and China in accordance with the international standard (ISO 14155).

Topics
  • Multinational clinical trials: before, during and at the end of the study
  • The regulatory framework for clinical trials in the US, Europe and China
  • International standard ISO 14155: Clinical investigation of medical devices for human subjects - good clinical practice
  • Country selection for multinational clinical trials
Aims and objectives

To access foreign markets, medical device companies need to perform clinical trials in the respective countries. From an organisational and economic point of view, it is useful to choose a concerted multinational and multicentre trial set-up.

However, multinational clinical trials are more time consuming and need more preparation, documentation and evaluation. ISO 14155 is an international standard for clinical investigations of medical devices.

In this course, you will learn about the efficient planning, implementation and termination of a multinational clinical trial in compliance with inconsistent regulatory requirements. Our experts feel right at home in the regulatory world and will show you the pitfalls and stumbling blocks of clinical investigations.

Who should attend

This online course addresses the needs of employees in the medical device industry and contract research organisations (CROs), in particular those who organise, accompany, implement and monitor international clinical trials of medical devices.

Detailed programme

Day 1: 14:00 - 17:00
Day 2: 10:00 - 17:00

Dr. med. Markus Hahn

Clinical investigations of medical devices in an international context
  • ISO 14155:2020: the standard for clinical investigations of medical devices - 'good clinical practice' and information
  • Normative reference to ISO 14971 and differences from ICH-GCP E6
  • Country selection for international studies
  • The role of and the exchange between ethics committees (ECs) and competent authorities (CAs)
  • GHTF and IMDRF

Dr. med. Markus Hahn

Clinical investigations in Europe: Germany, France, Italy, Spain and the UK
  • The European regulatory framework (EU) 2017/745
  • Relevant MDCG documents
  • National specifics
  • Preparation, implementation and finalisation
  • Monitoring, audits and inspections
  • Changes and end of study (data analysis, clinical report)
  • Project and budget plans, time management

Autumn Lang

Clinical trials in the US
  • US RA Pathways
  • Risk assessment and reasoning of conduct of a clinical study
  • Pre-submission meetings
  • Content of an IDE
  • Preclinical and OUS data
  • Preparation, management and end of study
  • Quality of the test product

Autumn Lang

Clinical trials in the US (part 2)
  • Quality of the test product
  • Necessary study documents
  • Follow-up submissions to the FDA
  • Monitoring, audits and important changes to be notified
  • Study documents, databases, study reports and publication
  • Project and budget plans and time management

Wenkai Ma

Implementation of clinical trials for medical devices in China
  • China Food and Drug Administration (CFDA) and Center for Medical Device Evaluation (CMDE)
  • Medical device registration regulations
  • Local testing requirements, including selecting an authorised testing agency, compiling local product specifications and testing implementation

Wenkai Ma

Implementation of clinical trials for medical devices in China (part 2)
  • Communication with authorities (CFDA, authorised testing centre, etc.)
  • Update on Chinese Medical Device Administration Regulations and clinical trials
  • Before, during and at the end of the study

Wenkai Ma

Implementation of clinical trials for medical devices in China (part 3)
  • Vigilance: AEs and SAEs reporting system
  • Local CROs, sales and logistics

Further information

How an online seminar works

  • The online seminars are live and interactive.
  • They are held and controlled directly by our speakers.
  • You may take part in the seminar from anywhere using your end device.
  • You will see the presentation and listen to our speaker’s lecture using Internet telephony (VoIP) or even a normal telephone connection.
  • You are invited to ask questions live and participate in discussions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your questions in advance

Please send us your questions concerning the seminar topics in advance to a.bauer@forum-institut.de. We will be happy to forward them to the speakers and adress the questions in the seminar.

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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