This course is co-developed and given by the Belgian Competent Authorities. European legislation is one thing; the practical implementation in Belgian is something else. The programme has been revised to include the most recent developments related to the implementation of the EU Clinical Trial Regulation 536/2014.
This 1-day course has been revised to capture the most recent developments and focuses on the current and future legal requirements of performing clinical trials with medicinal products in Belgium.
The Belgian law of 7 May 2004 on experiments on humans implements the European directive 2001/20/EC is currently valid. A number of Royal Decrees and circular letters have also been published, which detail the practical implementation of the law. This training helps participants understand how the present Belgian legal rules should be applied.
A separate part of the training is dedicated to the European Clinical Trial Regulation 536/2014, which will become applicable in 2016 and which will repeal directive 2001/20/EC after a transition phase.
Information relating to steps under development for implementation in Belgium will be presented.