Xinhua Qian

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AbbVie, Inc
Principal Scientist II in the Scientific Affairs Group, Process R&D
Xinhua Qian is a Principal Scientist II in the scientific affairs group, process R&D, at AbbVie, Inc. His main responsibilities include contributing to development of control strategy for drug substance manufacturing and authoring the CMC documents for regulatory submissions. Previously he was a Process Chemist with Bristol Myers Squibb. Xinhau earned a BS in chemistry from Fudan University, Shanghai, China, and a PhD in organic chemistry from the University of Arizona. He completed his postdoctoral research fellowship at the Scripps Research Institute.

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Figure 3: Industry develops a single global control strategy.
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During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. This article shares data that highlight instances where well-established ICH...