Clinical Trial Materials Interest Group

Group Leader : 
Galen Shi
Director of CT Manufacturing
Eli Lilly and Company
Email: galen_shi@lilly.com

The Clinical Trial Materials Interest Group offers members an opportunity to discuss topics of interest associated with the development and manufacture of clinical supplies. This includes the pre-clinical phase (involving pharmaceutical development operations), the manufacture of all phases of clinical supplies (including both API and drug product), and the ultimate transfer of the manufacturing process to the commercial manufacturing site.

This group offers a valuable opportunity to interact with professionals and regulators alike to share ideas, discuss opinions, and offer advice to each other in this very complex area of the pharmaceutical business. When deemed appropriate by the group, position papers may be drafted and feedback on proposed regulations may be given.

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