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87 news items
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MREC NedMec ready for review of research files
As of 15 April 2022, MREC NedMec, the result of the merger of MREC AVL and MREC Utrecht on 1 January 2022, offers review of ...
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Therapeutic vaccines now only reviewed by MRECs
Based on the Central Review of Medical Research Involving Human Subjects Decree ( Besluit Centrale Beoordeling), the assesment ...
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New online tool makes CTR scope more transparent
The new Clinical Trial Decision Tool helps you to determine whether your study with a medicinal product falls within the scope of ...
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CCMO kicks off programme on patient participation in clinical trials
To promote patient participation in clinical trials, CCMO is launching a programme to cooperate actively with other parties. ...
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New EMA document for sponsors on CTIS
The European Medicines Agency (EMA) has published a new document on the Clinical Trials Information System (CTIS). The document ...
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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.
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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 ...
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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 ...
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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 ...
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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 ...