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By Ricardo Torres-Rivera, Xevalics Consulting, LLC | Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure. | |
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By Richard Steiner, Pharmatech Associates | The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest. | |
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By Arundhati Sengupta, Mirum Pharmaceuticals | To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays. | |
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