Notifications about clinical trials
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The European Commission has published three recommendations for the clinical trials regulation
| 14 November 2017 |
In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.
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Annual report 2016 - Clinical trials of medicines
| 13 June 2017 |
LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.
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New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems
| 13 February 2017 |
The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials.