Celeste Cagnazzo, Clinical Research and Development Unit Manager at the Regina Margherita Children’s Hospital, shared a post on LinkedIn:
“The fact that AIEOP has decided to dedicate an entire session to the impact of R3 on non-profit promoters and clinical centers is yet another confirmation that the culture in clinical research is profoundly changing.
It is undeniable that the AIFA determination on Phase I studies was a fundamental driving force. The last obstacle is missing: the Directorates-General.
Being compliant with some R3 requirements necessarily requires the involvement of the upper floors, without which a whole series of improvements can never be implemented.”
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