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This MasterClass will be held in French 🇫🇷

 

Description

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When setting up a clinical trial (clinical evaluation of a medical device or drug), the responsibilities related to the management and monitoring of the trial are divided between the investigators and the sponsor. This training will give you a global vision of “who does what and how” in compliance with Good Clinical Practice (GCP).
This training is aimed at researchers and/or start-up actors (biotech, medtech or digital) who will be – in the short, medium or long term – required to carry out clinical trials as part of their research or as part of the development of a drug or medical device.

Prerequisites: no

 

What you will learn

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Participants will be able to position themselves in :

• Become familiar with “Good Clinical Practice (GCP)
• Know the ethical principles of clinical research
• Understand the role and responsibilities of the sponsor and the investigator
• Be familiar with the regulations and vigilance in clinical research
• Be familiar with the use of data and the respect of the European Data Protection Regulation (RGPD)

 

Content of the training

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• Good Clinical Practice (GCP)
• Background
• Ethical principles and clinical research
• Definition and role of the sponsor
• Definition of the investigator
• Regulations
• Responsibilities of the investigator and sponsor
• Sanctions
• Vigilance
• RGPD

 

Teaching team

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Ressources

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• The training material in pdf format
• Useful links to go further