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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 ...
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Evaluation procedure VGO local feasibility started
Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...
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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): ...
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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 ...
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New version Investigational Medical Device Dossier (IMDD) template available
A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the ...
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From 1 December 2020 modified procedure for submitting local feasibility declaration
From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In ...
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Guidance for MRECs on medical device investigations
As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. A new guidance sets out the implications for the ...
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New Subject Information Sheet for adults now available
A new template for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO ...
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Register medical devices investigations with CCMO? Online tool offers a solution
From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...
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From October 2020, CCMO will meet twice a month
As of October 2020, CCMO will hold two meetings a month instead of one.