Guidance for the assessment of minors

Guidance for the assessment of minors

Last week, on March 1, 2017, the amended Medical Research Involving Human Subjects Act (WMO) went into effect. The Dutch Association of Medical Ethical Testing Commissions (NVMETC) and the Central Commission of Human-Related Research (CCMO) have written a testing...
ICH-GCP revision is adopted

ICH-GCP revision is adopted

It’s happened: on November 17, 2016 the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopted the revisions of the Good Clinical Practice directive (ICH-GCP E6 R2). Does that mean that the...