For which studies does the sponsor need to be recognised as non-commercial sponsor in Belgium and how should this recognition be requested?
For academic studies under the Belgian experiment law (May 7th 2004) or the Medical Device…
For academic studies under the Belgian experiment law (May 7th 2004) or the Medical Device…
Experiment (refer to submission package and procedure for Experiments) An experiment is defined as “Every…
For experiments under the law of May 7th 2004, retrospective studies, studies on residual human…
The biobank medical manager is responsible for the various responsibilities imposed by the Royal Decree…
According to section 4 of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP),…
HIRUZ has a GCP course available, which can be followed free of charge via POL…
Human biospecimens are defined as any biological material taken from a human individual for diagnostic…
According to TIME magazine in 2009, biobanks were one of the ten things that were…
End of trial (i.e. the last visit of the last patient – LPLV) needs to…
Within a year after the end of trial (i.e. the last visit of the last…