Regulatory Courses
Part of a STAR Programme

Clinical Research is one of the most regulated industries in the world. Not a surprise, as we are dealing with research involving human beings. Therefore safeguarding study participant’s rights, wellbeing and safety is of utmost importance. This is why before starting a clinical trial, you need to obtain appropriate approvals. Authorities and Ethics Committees play a major role in this approval process.

This ½ day course is designed to provide basic understanding of the current regulatory requirements for Clinical Trials for people who have limited or no background in these matters.

Course time
09h00 - 12h30
Who should attend

People starting in the clinical research field in operational roles as well as people in other domains, who want to have a clear and basic understanding of clinical trial rules.

Programme highlights
  • Clinical trials
    • Why and When
    • Difference with regular medical practice
  • Rules for clinical research:
    • History (tragic mistakes)
    • Declaration of Helsinki
    • ICH-Good Clinical Practice
    • Legal framework
  • Definitions and frequently used abbreviations (plus exercise)
  • Getting the approval for starting a clinical trial
    • Process
    • Documents
  • Workshop on starting up a clinical study (with a real live simulation)
Learning Objectives
  • Understand the basic concepts of and obtain a clear view on the clinical research regulations and how they came to existence
  • Be able to identify what is needed in order to get the required approvals to start a clinical study
  • Get familiar with terminology and abbreviations

Book a course

Date Lang Location
Proceeding your application may take up to 24 working hours. In case of question, contact
300,00 € excl. VAT (if applicable)


Chiara Zavattaro
July 2018

The trainer was FANTASTIC. She knew a lot, was extremely friendly, and was open to reply (and she knew the answer to) any question on the topic