Create a reliable supply chain for autologous cell therapies that maintains compliance and ensures product safety and integrity.

On January 31, 2022, European Union (EU) member states became legally required to enforce the Clinical Trials Regulation (CTR) No. 536/201, intended to replace the Clinical Trials Directive (2001/20/EC), which had often been criticized.

Learn the differences in areas of expertise, focus and responsibilities between the Clinical Supply Manager, the Project Manager, and the Financial Project Analyst.

How an FPA can provide cost savings to sponsors.

How demand-led supply and DTP distribution can shape a DCT.

How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.

Learn the differences in areas of expertise, focus and responsibilities between the Clinical Supply Manager, the Project Manager, and the Financial Project Analyst.

Learn how early collaboration with an integrated solutions provider can help to mitigate supply challenges.

Which therapeutic areas are ripe for highly decentralized trials? Which areas will be least resistant to this kind of change?

Summary: Catalent’s clinical supply packaging facility in Shiga, Japan is strategically located between Tokyo and Osaka. One of largest in Japan, the 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global...