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New European documents with recommendations available for clinical trials
The European Commission has published three new documents with recommendations for clinical trials. The documents are the result ...
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CCMO and Paul Janssen Futurelab are developing a new online course on clinical research
On 26 June 2017 the CCMO and Paul Janssen Futurelab (a new Leiden University Medical Center initiative) signed an agreement aimed ...
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Completion EU clinical trial portal postponed to 2019
The European web portal and the European database for clinical trials will be completed in 2019 instead of October 2018, as ...
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EU regulation established on inspection procedures for clinical research with a medicinal product
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Joop van Gerven appointed as new CCMO chairman
As of 15 June 2017, professor JMA (Joop) van Gerven will assume his duties as the new chairman of the Central Committee on ...
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Regulations for medical devices and in vitro diagnostics adopted by European Parliament
On April 5, 2017 the European Parliament adopted a regulation for medical devices and a regulation for in vitro diagnostics. The ...
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Template Subject Information changed
The Template Subjects Information, which is used to compile the research subject information leaflet, has changed. The immediate ...
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Reporting procedures SAEs, SUSARs and SADEs available in flowcharts
The reporting procedures for SAEs, SUSARs and SADEs are available in flowcharts (in Dutch) on the website of the CCMO. The ...
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Changed Guideline for Good Clinical Practice