European Directives for Clinical Research – Implementation in Belgium

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Startdata en plaatsen

Brussels
26 sep. 2019

Beschrijving

European Directives for Clinical Research – Implementation in Belgium

Course Description

This one day course focuses on the legal requirements of performing clinical trials with medicinal products in Belgium.
The Belgian law of 7 May 2004 on experiments on humans, implements the European directive 2001/20/EC. A number of Royal Decrees and circular letters have also been published, which detail the practical implementation of the law. This short course contains a number of illustrations and practical examples to help participants understand how these Belgian legal regulations should
be implemented in practice. This course is continuously updated with the latest information on requirements.

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European Directives for Clinical Research – Implementation in Belgium

Course Description

This one day course focuses on the legal requirements of performing clinical trials with medicinal products in Belgium.
The Belgian law of 7 May 2004 on experiments on humans, implements the European directive 2001/20/EC. A number of Royal Decrees and circular letters have also been published, which detail the practical implementation of the law. This short course contains a number of illustrations and practical examples to help participants understand how these Belgian legal regulations should
be implemented in practice. This course is continuously updated with the latest information on requirements.

Learning objectives

• To provide an overview of the implementation of the EU directive into Belgian law
• To detail the practical implementation, illustrated with examples
• To understand all Belgian laws related to Clinical Research

Programme highlights

• History and background of the EU directive and its implementation in the Belgian law
• Provisions of the Belgian law, the Royal Decrees and circular letters:
• Clinical trial authorization from Ethics Committees and Authorities
• The IMPD, Qualified Person and Legal Representative
• Safety reporting
• Inspections Clinical Trial Applications to the Belgian Competent Authority
• Role of the Competent Authority, focusing on practical experience
• Update on guidance documents
• Mdeon

Who should attend

Everyone involved in clinical research, including: Pharmaceutical companies, CROs, Investigators, Site Personnel and Ethics
Committee Members
People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments within the pharmaceutical industry

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

Trainer: Mr. Bonnarens (FAGG) & Marleen Verbeeck, PhD / Gerald Van Roey

Language: English

What did our participants think? Ms. Gerda Sabbe - EU Clinical Trial Directive: implementation in Belgium participant 2010 - Medical Device Works

I would like to thank the trainers of ECCRT with the course: "EU Clinical Trial Directive: implementation in Belgium". Even though my current interest is mostly in "medical devices", I learned a great deal from both Mr. Bonnarens and Dr. Verbeeck. The information was presented very well, even though the materials can, in itself, be quite boring. In addition the practical handeling of the subscription, reception, training, breaks and conclusion of the meeting went smoothly: congratulations.

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Heb je een vraag? Onze adviseurs helpen je graag. Bel ons op 085 7440830 of e-mail naar info@springest.nl.

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