Chemistry, manufacturing and controls training course
In submitting a dossier for a clinical trial approval or a new drug, regulatory personnel are required to submit information relating to chemistry, manufacturing and controls abbreviated as CMC.
The information required is updated regularly to comply with the regulations. The actual information can be found in the regional guidance documents as well as ICH guidelines.
In this course we will discuss the content of the CMC for clinical trials and drug marketing approval requests according to the ICH guidelines, FDA regulations and Food and drug regulations.
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