Aml Research

Regulatory submissions of clinical investigations with devices in Belgium

Major topics of the training:

The course is a comprehensive guide to the basic regulatory aspects of setting up and conducting a clinical investigation with a medical device in Belgium according to the Belgian law of 7 May 2004 on experiments on humans, the royal decrees and circular letters  clarifying its implementation.  This course is updated whenever new information is published. Practical examples illustrate the course.

Content:

  • Legal framework
  • Initial submission to Competent Authority and Ethics Committee(s)
  • Reporting during clinical trial to Competent Authority and Ethics Committee(s)
  • Reporting after end of clinical trial to Competent Authority and Ethics Committee(s)
  • Other regulations to consider

Who should take the course?

Clinical research professionals involved in conducting clinical investigations with medical devices in Belgium. There is no prerequisite for this course but participants will benefit from an understanding of what a clinical trial is about and having a basic understanding of the clinical trial regulatory and good clinical practices environment.

Duration: 90 minutes


Price:  340€ (Excluding VAT chargeable in Belgium and EU)


Course dates (webinar):

  • Monday March 6, 2017 at 14:00 CET
  • Thursday June 22, 2017 at 11:00 CET
  • Tuesday October 3, 2017 at 11:00 CET

Booking on to a course: 

If you want to register for this course, please send an email to training@aml-research.be and mention:

  • Course title
  • Course date
  • Title, First Name, Last Name and email addresses of trainees
  • Invoice details

Requests for registration should be send at least 3 days (72 hours) prior to the course date.

We will then provide you via email with a confirmation of registration and further information.