Notre projet stratégique
“Pour répondre aux orientations inscrites dans le Contrat d’objectifs et de performance qui nous lie avec l’État, notre établissement a défini son projet stratégique « EFS 2028 : plus loin ensemble ». ” En savoir...
“Pour répondre aux orientations inscrites dans le Contrat d’objectifs et de performance qui nous lie avec l’État, notre établissement a défini son projet stratégique « EFS 2028 : plus loin ensemble ». ” En savoir...
Symbole de cet engagement, l’établissement vient de créer une direction nationale dédiée à la production de biomédicaments. Objectif : renforcer l’activité des plateformes de production de l’EFS et participer ainsi aux objectifs fixés par le...
MHRA has provided information on the new regulations for decentralised manufacture which come into effect on 23 July 2025. Point of care and modular manufacture are collectively called decentralised manufacture. These processes allow medicinal products...
The FDA has issued a draft guidance, which describes considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. It discusses related quality considerations for drug products that...
FDA has issued a final guidance for industry entitled “Advanced Manufacturing Technologies Designation Program.” This guidance provides recommendations to persons and organisations interested in participating in the program, which facilitates the development of drugs manufactured using Advanced...
Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU)...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that...
This scientific view reflects the opinion of independent experts (MDR Article 106.1) on the performance evaluation report (PER) of the manufacturer. The advice is provided in the context of the performance evaluation consultation procedure (PECP),...
The Advanced Therapies Europe 2024 conference in Estoril, Portugal, set the stage for crucial discussions about the future of cell and gene therapy (CGT) manufacturing. As the industry stands on the brink of scaling these...
Committee Science and Technology Committee (Lords), Inquiry University Spin-out Companies The session will focus on the independent review of university spin-out companies; the challenges faced by companies wanting to scale up; and what the Government could do...