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February 01, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
January 15, 2024
Harmonization of global regulations fosters innovation and ensures quality medicines.
FDA is anticipating how AI may advance manufacturing and improve supply chain security.
The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.
January 03, 2024
Revolutionary therapies restructure pharmaceutical manufacturing.
A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.