Clinical Operations Courses

European legislation is often far away from daily routine in clinical trials, yet during this course you receive all necessary information in a very practical way. You get the ins and outs of several legislations, such as the clinical trial directives, showing the consequences for you. After this course, European legislation will hold no more secrets for you!


This one-day course is designed to provide a clear understanding of the current regulatory requirements for Clinical Trials with investigational medicinal products in Europe.

Essentials of the current European Directives 2001/20/EC, 2005/28/EC and the Voluntary Harmonisation Procedure (VHP) are explained. Current requirements for submission and approval procedures of clinical trial applications, safety reporting, substantial amendments, and the publication of trial results are explained. You will learn about non-commercial and post-authorisation safety trials. The state-of-the-art regarding implementation and implications will be presented. Much attention of the course goes to the implementation of legislative requirements and guidance documents in practice.
In addition, the European Clinical Trial Regulation 536/2014 which will be the future legislative obligatory requirements is outlined. And finally, an overview updates you on other legislations with topics related to clinical research.


Course time
09:00 - 17:00
Who should attend

Everyone involved in clinical research including: pharmaceutical companies, Contract Research Organisations (CROs), investigators, site personnel and ethics committee members.
People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.


Programme highlights
  • Review of key areas of the directives and implementing European legislative texts
  • Clinical trial authorisation from ethics committees and authorities
  • Substantial Amendments and Safety reporting
  • Post-Authorisation Safety studies
  • Voluntary Harmonisation Procedure
  • Outline of the Clinical Trial Regulation 536/2014



Book a course

No session currently available.
In case of interest, please contact us.