Papers and Presentations
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Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum
CMC Summary Paper: CMC Strategy Forum Japan 2013
CMC Summary Paper: Practical Use of Expanded Change Protocols
CMC Summary Paper: CMC Strategy Forum North America Winter 2013 - 2
Paradigms for Process Validation - A Practical Approach
CMC Summary Paper: CMC Strategy Forum North America Winter 2013
Biological Product-specific Reference Standard - Best Practices - Part 1 and 2
CMC Summary Paper: CMC Strategy Forum North America Summer 2013
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For 2021 meetings, content will be available for one year after the program. For 2022 and beyond, content will be available for three months.