European Commission – Sponsor Responsibilities with regard to Handling and Shipping of IMPs (Cell and Gene Therapy Catapult – Regulatory Round-up – January 2023)
The “Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice” came into effect on the 1st of January 2023. This guideline lays down the principles for the two-step release and shipping of Investigational Medicinal Products (IMPs) by the Qualified Person (QP) and the Sponsor in accordance with good clinical practice (GCP) and good manufacturing practice (GMP).
See all of Catapult’s Regulatory Round-up for January 2023 here. Published on the 1st of February 2023.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (17 mai 2023). European Commission – Sponsor Responsibilities with regard to Handling and Shipping of IMPs (Cell and Gene Therapy Catapult – Regulatory Round-up – January 2023). ELSIBI. Consulté le 12 octobre 2026 à l’adresse https://doi.org/10.58079/o6ax
