EUCROF comments on recent consultation documents
End of August was the deadline for commenting a number of consultation documents which were prepared by the EU Commission and which are supportive for theinterpretation of the EU Clinical Trials Regulation 536/2014. The EUCROF Clinical Trials Legislation Working Group (CTL WG) was active and submitted comments in a timelymanner. I would like to express my thanks to all who participated!
Please find the respective consultation documents plus the EUCROF comments:Risk proportionate approaches in clinical trials EUCROF Comments on Risk proportionate approaches in clinical trials_final_20160826 Summary of Clinical Trial Results for Laypersonst EUCROF Comments on Summary of Clinical Trial Results for Laypersons_final_20160826 Definition of IMPs and use of AMPs EUCROF Comments on Definition of IMPs and use of AMPs_final_20160829.
In case of questions please do not hesitate to contact me.
Best wishes
Dagmar Chase
Vice-President EUCROF
Chair of the CTL WG
Assia Rosati
EUCROF Admin. support
