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CMC Summary Paper (4)

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2013

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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