On 27 Sep 2021, the Innovative Medicines Initative Consortium IDEA-FAST submitted a request for an initial CHMP (Committee for Medical Products for Human Use) qualification advice to discuss the results of the Feasibility Study and acceptability of the proposed design of the Clinical Observational Study for supporting the future EMA qualification procedure for the proposed endpoints use in clinical trials. The IDEA-FAST IMI consortium requested CHMP’s feedback on the unmet measurement need in the proposed context of use, concepts of interest and selected technologies, method for demonstrating sensitivity to change, study design, data analysis methodologies and acceptability of cross-disease digital biomarkers approach. The meeting with the CHMP is expected in Feb 2022 and the overall outcome by beginning of Apr 2022.
The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use: https://www.ema.europa.eu/en
This article was originally posted on: https://idea-fast.eu/idea-fast-qualification-advice-request-submitted-to-ema/