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Chemistry, Manufacturing, and Controls define the language through which a drug’s quality is understood by regulators. Every formulation, process, and test eventually finds its way into the CMC section of the Common Technical Document, the core of any submission in Canada or the EU.
This workshop brings together the scientific and regulatory sides of that process. It explains how CMC data is compiled, structured, and reviewed, and how a well-organized submission can determine the speed and outcome of approval. Participants learn what regulators expect when it comes to manufacturing controls, analytical methods, validation, and stability testing, along with how to present this information clearly and in full compliance with global standards.
It is designed for professionals working in regulatory affairs, quality assurance, and product development who manage or contribute to CMC documentation. The discussion focuses on accuracy, clarity, and the reasoning behind every requirement, giving attendees a deeper sense of how technical precision translates into regulatory confidence.
The session is led by Andy Tallevi, Formulation and Process Consultant at Keller Consulting, who brings nearly three decades of experience in pharmaceutical development. Having worked with Health Canada and GlaxoSmithKline, he offers a rare perspective that bridges formulation science with regulatory insight, shaped by years of hands-on experience in both industry and government review. | 
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