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Answers to frequently asked questions about the European Clinical Trial Regulation
Set of European guidance documents for clinical trials
Guidance documents for clinical trials are available on the website of the European Commission.
Combining progress report with safety report in research with a medicinal product
In research with a medicinal product, the annual progress report may be combined with the annual safety report. The CCMO takes ...
New European ethical considerations for research with minors
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 ...
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 ...
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 ...
EU regulation established on inspection procedures for clinical research with a medicinal product
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 ...
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 ...