by GCP Central | Mar 9, 2017 | GCP Central News
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...
by GCP Central | Nov 2, 2016 | GCP Central News
Modified from original article on www.CCMO.nl On Tuesday, October 25, 2016, the Dutch Senate approved a bill to amend the Medical Research Involving Human Subjects Act (WMO). It is expected that in practice, this amendment will allow more room to develop new treatment...
by GCP Central | Oct 13, 2016 | Experiences
Since January 2016 The Tweesteden hospital and the St. Elisabeth hospital merged to form the Elisabeth-Tweesteden Hospital (ETZ). It is one of the 26 cooperating top clinical hospitals (STZ) in Netherlands. That means extra attention to training and research. Marika...
by GCP Central | Oct 13, 2016 | GCP Central News
Source: Dutch Senate website There is currently a bill in the Dutch Senate to amend the Medical Research Involving Human Subjects Act (WMO). The aim of this amendment is to expand the possibilities for conducting (non-therapeutic) medical-scientific research with...
by GCP Central | Oct 13, 2016 | GCP Central News
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...
by GCP Central | Jul 21, 2016 | GCP Central News
The ICH Guideline “Good Clinical Practice” (the E6 directive) is in revision. This revision will impact the ICH-GCP requirements worldwide. This is a special moment because this is the first change since the GCP directive 20 years ago was published....
