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72 news items
CCMO closed between Christmas and New Year’s Eve
Due to the holiday season, CCMO will be closed from Monday 27 December 2021 to Monday 3 January 2021.
Information EU Clinical Trial Regulation available on CCMO's website
On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply with new rules for research with medicinal ...
New directive makes use of Site Suitability Declaration (VGO) obligatory for research with a medicinal product as of 1 November 2021
CCMO’s directive on the assessment of the suitability of research centres (TGO) has been adopted and will apply to studies with ...
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 ...