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Course — Preparing the CMC Section for MAAs-IMPDs

19th November 2018 - 20th November 2018
Berlin, Germany


This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).

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