CLINICAL SUPPLY REGULATORY ARTICLES

GettyImages-1134960690 EU Reg. 536/2014's Expiry Label Requirement Forces Us Backward, Not Forward

In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.

CLINICAL SUPPLY REGULATORY VIDEOS

Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.

Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.

This webinar aims to introduce the main regulatory themes, as well as provide a practical insight into converting regulatory theory to practical steps to enable DtP on global studies. 

Achieving supply chain resilience is crucial, and flexible distribution strategies and ready-to-use depot and logistics networks are instrumental in establishing limitless flexibility and expertise capable of identifying possible risks.

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