Consultation on Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources (Cell and Gene Therapy Catapult – Regulatory Round-up – October 2022)
EMA has published a good practice guide for the use of the metadata catalogue of real-world data sources for consultation. The catalogue is intended to facilitate the discovery of data sources to generate evidence for regulatory purposes and to support the assessment of study protocols.
In the draft guide, EMA and the Heads of Medicines Agencies describe how assessments of sources should consider quality in relation to both the reliability of the primary data and the relevance of the data source. EMA has provided a use case to describe a six-step process for identifying suitable data sources.
The draft is open for comment until 16 November 2022. EMA is aiming to release the catalogue late next year.
See all of Catapult’s Regulatory Round-up for October 2022 here. Published on the 7th of November 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). Consultation on Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources (Cell and Gene Therapy Catapult – Regulatory Round-up – October 2022). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/o673





