National Costume: Want to work in Regulatory Affairs? Get trained on CMC today!

Monday, February 27, 2023

Want to work in Regulatory Affairs? Get trained on CMC today!

Greetings!

The objective of this course is to provide a strong understanding of the importance and underlying principles for CMC requirements from the regulatory perspective. Participants will gain an understanding of the CMC portion of a Common Technical Document (CTD) which is the format that regulatory submissions in Canada and the EU must be filed.

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Course Outline

The following specific topics will be addressed in detail:

Role of CMC in drug development
Nomenclature and characterization of drug substance
Analytical methods and validation
Manufacturing, in-process controls and process validation
Developing drug substance and drug product specifications
Stability, stability-indicating tests and how much change is acceptable
Regulatory expectations for product characterization
Drug Master Files
Structure, content and components relating to CMC section of a regulatory submission