Sideinnhold
CTR/CTIS information webinars
The Norwegian Medicines Agency has planned two CTR/CTIS information webinars in January 2022. Please note that the webinars will be in Norwegian. You can find further information (also in Norwegian) regarding the webinars here:
https://legemiddelverket.no/nyheter/informasjonsmote-om-nytt-regelverk-for-klinisk-utproving-av-legemidler
Training, user-testing and CTIS sandbox
The Norwegian Medicines Agency has been participating in EMAs user-testing of the new clinical trial platform CTIS as well as taking part in their Master Trainer Programme. We were given access to the CTIS sandbox in October 2021 and have been testing the functionality in CTIS, also with other EU member states (ongoing) and sponsors (planned).
VHP and VHP+
In order to prepare us for the upcoming regulation, the Norwegian Medicines Agency participated in the Voluntary Harmonisation Procedure (VHP and VHP+). This Procedure ended on the 1st of October 2021.
By taking part in VHP, The Norwegian Medicines Agency and Regional Ethics Committee gained useful experience with coordinated assessments of their clinical trial applications, both nationally and with the other EU member states.
