Aml Research

Regulatory submissions of clinical investigations with devices in The Netherlands

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 the Netherlands according to the Medical Research in Human Subjects Act (“WMO”) and it’s updates.  This course is updated whenever new information is published. Practical examples illustrate the course.


  • 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 The Netherlands.

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):

  • Friday March 20, 2020 at 11:00 CET
  • Tuesday June 23, 2020 at 14:00 CET
  • Thursday October 15, 2020 at 11:00 CET


Booking on to a course: 

If you want to register for this course, please send an email to 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.