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This workshop is designed to help participants build a clear, practical understanding of Chemistry, Manufacturing, and Controls (CMC) from a regulatory standpoint. CMC is one of the most critical parts of any regulatory submission, and this session focuses on why it matters, how it is assessed by regulators, and how it should be presented within the Common Technical Document (CTD) for Canada and the EU. Participants will learn how to compile and organize CMC information in a way that supports compliance, clarity, and successful regulatory review.
The session is well suited for professionals working in regulatory affairs, quality assurance, and product development within the pharmaceutical and biopharmaceutical space. It is particularly relevant for those involved in preparing, reviewing, or managing CMC content, including regulatory submission specialists, technical writers, project managers, and quality and analytical teams. Consultants and others who support regulatory submissions will also benefit from gaining a stronger understanding of how CMC expectations are applied in practice.
Participants will be guided through the role of CMC across the drug development lifecycle, from drug substance characterization and nomenclature to analytical methods and validation. The workshop also covers manufacturing processes, in-process controls, process validation, and the development of meaningful specifications for drug substances and drug products. Stability testing, stability-indicating methods, and how to manage acceptable post-approval changes are discussed in the context of regulatory expectations.
By the end of the workshop, participants will be more confident in understanding and preparing the CMC section of regulatory submissions. They will gain practical insight into how regulators evaluate CMC data, how Drug Master Files are used, and how to structure and present information clearly and effectively. The goal is to enable participants to contribute to stronger, more defensible submissions that support product quality and regulatory compliance. | 
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