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ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done.

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Enabling Global Pharma Innovation: Delivering for Patients

ISPE

This article describes the goal of the initiative, characterizes the anticipated challenges to innovation, summarizes the industry’s need to innovate, and discusses regulatory initiatives that are currently in progress, including learnings from the recent pandemic. 22 June 2023. EMA/321483/2020. 3 July 2020. www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf

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