CTIS & EudraVigilance – Update for Sponsors of Clinical Trials (Cell and Gene Therapy Catapult – Regulatory Round-up – July 2022)
The EMA launched the enhanced EudraVigilance system in November 2017 to support the reporting and analysis of suspected adverse reactions (SARs) from clinical trials and the post-approval phase of medicines.
The use of the ICH E2B (R2) format will therefore be phased out. For more information, see change management for the EudraVigilance system.
See all of Catapult’s Regulatory Round-up for July 2022 here.
Published in August 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (26 octobre 2022). CTIS & EudraVigilance – Update for Sponsors of Clinical Trials (Cell and Gene Therapy Catapult – Regulatory Round-up – July 2022). ELSIBI. Consulté le 25 avril 2025 à l’adresse https://doi.org/10.58079/o63x