News - Latest
60 news items
Sort by: Date / Relevance
Rates established for assessment of research under CTR and MDR
The Ministry of Health, Welfare and Sport has set the rates for medical ethical review in the Netherlands of research under the ...
Clinical Trial Regulation (CTR) applicable from 31 January 2022, VHP concludes on 15 October 2021
On 31 July, the European Commission has announced in the Official Journal of the European Union that the Clinical Trial ...
Site Suitability Declaration (VGO) as of 1 November 2021 obligatory for research with a medicinal product
As of 1 November 2021, use of the Site Suitability Declaration [Verklaring Geschiktheid Onderzoeksinstelling, VGO] will become ...
Changes in CCMO's assessment task for specific types of research
CCMO’s assessment task has been adapted for specific types of research. These adaptations have been laid down in the Dutch ...
Information EU Medical Device Regulation available on CCMO website
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR) has come into effect. The MDR contains specific rules for ...
CCMO reviews research on cell therapy, gene therapy, other products that specifically influence the functioning of the genetic material and medicinal products with GMO
CCMO’s website clarifies when CCMO is the designated review committee for certain types of research.
Clinical Trial Regulation to apply from January 31, 2022
The European Medicines Agency (EMA) has confirmed that the development of the Clinical Trials Information System (CTIS) is on ...
Evaluation procedure VGO local feasibility started
Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...
Clinical Trial Regulation expected to apply from January 31, 2022
The European Medicines Agency (EMA) has announced a new expected go-live date of the Clinical Trials Information System (CTIS): ...
Risk inventory important for conduct of clinical research
Yesterday, the cabinet declared a lockdown to reduce the spread of the coronavirus. In response to this, CCMO would like to draw ...