Reasons to attend

European legislation is often far away from daily life, yet in this interactive eLearning course you receive all necessary information in a very practical way. You will get a clear understanding of the current regulatory requirements for Clinical Trials with investigational medicinal products in Europe.

The European Clinical Trial Regulation 536/2014 (CTR) is already in place since 2014 and will replace the current EU Clinical Trial Directive 2001/20/EC (EUCTD). However, since the CTR is not effective yet, today, the EUCTD is still in force.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course schedule

• Course credit: 5h (3 months period to complete course)
• Complete the course at anytime, anywhere!

Course Description

Essentials of the current European Directives 2001/20/EC, 2005/28/EC and the Voluntary Harmonisation Procedure (VHP) are explained. 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. Note however, that in order to have the latest implementation status of the CTR, we recommend you to follow our webinar “The European Clinical Trial Regulation 536/2014 - A Clear Outline“. Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment.

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.