You need a clear and hands-on understanding of the national regulatory legislation for Clinical Trials with investigational medicinal products but also medical devices in Belgium?
This eLearning course will fulfil your expectations in a very practical way. It is an interactive approach to review and comprehend the actual Belgium legislation framework, and you can learn at your own pace. Interactive quizzes for self-assessment are included to provide a better understanding of the course. You will be able to test your comprehension with a final grading assessment
This eLearning is only covering how Belgium is applying the Clinical directive 2001/20/EC within the Clinical Trial Belgium law dated 7th May 2004.
If you want to complete your knowledge with what is the content of the new Clinical Trial Law dated 7th May 2017 and the Royal decree linked to it, we invite you to register also to our webinar titled “The Belgian Clinical Trials Law of 2017: A Clear View on New Rules”. Register to both courses at once and get a € 100 discount (contact us at info@eccrt.com for more details).The more Local Clinical Trial Legislation courses you take the less you pay per course: click here to know more!
Programme highlight
Legal Framework governing clinical trials with investigational medicinal products and medical devices
Process, timelines and fees for achieving clinical trial authorisation from the competent authorities (Ethics Committee and National Competent Authorities)
Amendments & End of Trial Notification
Safety Reporting
Learning objectives
Get an overview of the local clinical trial legislation in both medicinal products and medical devices
Be able to identify and create legally required documents
Know the procedures to be compliant and reach successful clinical trials submissions.
Who should attend
Everyone involved in clinical research, including: Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel.
People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments involved in monitoring activities (on-site or medical monitoring) of investigational sites.
Everyone who wants to acquire knowledge of the Local Regulatory Requirements.
Everyone who needs to comply local regulatory training requirements prior to performing work locally.
Investigational Product Development and Regulation (1)
Clinical Studies Operations (GCPs or ISO 14155) (2)
Study and Site Management (0)
Data Management and Informatics (0)
Leadership and Professionalism (0)
Communication (0)
Teamwork (0)
Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
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