News about clinical trials
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For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
| 06 March 2026 |
See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs
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New functionalities in the CTIS-module Non-substantial modification
| 09 February 2026 |
It is now possible to submit non-substantial modifications, where it earlier required submission of a substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities below and on our homepage.