Glossary

Module 3

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This is the quality (or CMC) module, which is a component of the common technical document used for the registration of pharmaceuticals for human use.

Module 3

Patient Information Leaflet (PIL)

Early Dialogues Working Party (EDWP)

Key CMC and NC considerations for cell and gene therapy development

Module 3

Chemistry, Manufacturing & Controls (CMC)

Regulatory Strategy & Submissions

Other glossary definitions

Patient Information Leaflet (PIL)

Early Dialogues Working Party (EDWP)

Key CMC and NC considerations for cell and gene therapy development