CMC Submissions in CTD Format Training Course :

This course will provide an in depth review of the chemistry, manufacturing and controls (CMC) requirements for development and ultimate submission to the FDA and European regulatory bodies in the new drug application (NDA). Emphasis will be placed on current FDA, European and ICH requirements for the filing of the quality section of the CTD for manufacturing, analytical, sterility and stability issues as they apply to the drug substance and drug product. In addition, details on supplemental applications for changes to an NDA will be presented focusing on SUPAC requirements.