Description

Regulatory Courses

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 [at] eccrt.com for more details).

All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.

Course time
At your own pace; the course will remain available online for you for 3 months after you register for it.------------------------ Course Credits: 1,5 hours
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.
Programme highlights
  • 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.

 

Competencies

This course covers competencies that are part of the ECCRT Competency Framework

  • Scientific Concepts & Research Design (0)
  • Ethical & Participants Safety Considerations (0)
  • 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

Book a course

Date Lang Location
* Book now and learn at your own pace within the next 3 months
Book a bundle and pay less
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
150,00 € excl. VAT (if applicable)