John K. Mark

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Amgen, Inc
Senior Manager in the Regulatory Affairs-CMC
John K. Mark is a Senior Manager in the Regulatory Affairs-CMC team at Amgen, Inc., managing Canada and International markets. He is a former Health Canada Senior Biologist and Quality Evaluator at the Centre for Evaluation of Radiopharmaceuticals and Biologics (CERB) and Research Chemist in Health Canada’s Center for Vaccines Evaluation. John obtained his MSc in physiology at the University of Manitoba developing noninvasive diagnostics and completed a PhD in biochemistry at the University of Ottawa with studies on protein structure-function relationships in therapeutic target proteins. John has over 15 combined years of experience in research, policy, and regulatory experience with expert knowledge of Health Canada’s regulatory processes and guidance.

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Regulatory Landscape for Raw Materials: CMC Considerations
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Regulatory Landscape for Raw Materials: CMC Considerations

A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...