Update of the EMA Reflection paper on the use of IRTs
EMA updated the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates; originally EMA/INS/GCP/600788/2011. It was updated in view of the entry into application of the Regulation (EU) No.536/2014, only to clarify that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the Clinical Trials Regulation.
Updated reflection paper EMA/61464/2022.
Read the news published by the Cell and Gene Therapy Catapult (CGTC) on 1 March 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
ehabib (16 mai 2022). Update of the EMA Reflection paper on the use of IRTs. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/o5xx
