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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen. “Eli

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Published January 2018. US Food and Drug Administration.