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X-WR-CALNAME:BIOTECanada
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X-WR-CALDESC:Events for BIOTECanada
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DTSTART:20261101T060000
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DTSTART;VALUE=DATE:20260728
DTEND;VALUE=DATE:20260730
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SUMMARY:Welcome to the CMC Strategy Forum North America
DESCRIPTION:Advancing Biomanufacturing and Global Regulatory Modernization\nThe 2026 CMC Strategy Forum North America will bring together global experts from regulatory authorities\, industry\, and academia to discuss advances in biomanufacturing\, regulatory modernization\, and global regulatory convergence. The topic for 2026 is “Advancing Biomanufacturing and Global Regulatory Modernization”. The two-day interactive program will feature presentations\, panels\, and networking opportunities designed to promote open dialogue and collaboration across the biopharmaceutical community. \nThe Forum will focus on CMC and regulatory modernization\, global harmonization\, and science- and risk-based approaches to ensure the reliable supply of quality medicine. Key topics will include phase-appropriate development strategies\, emerging manufacturing approaches\, and the supporting and evolving regulatory and quality frameworks. \nA dedicated session on global convergence will highlight experiences from international collaborative initiatives\, with a focus on strengthening reliance\, work-sharing\, and regulatory alignment to accelerate global acc \ness to biologic therapies. \nParticipants will be able to evaluate how traditional quality guidelines are being applied within flexible\, data-driven\, and risk-based CMC frameworks to support innovation and lifecycle agility. \nClick this link to open the scientific program in a new tab. View the full Forum abstract below
URL:https://www.biotech.ca/event/welcome-to-the-cmc-strategy-forum-north-america/
LOCATION:Ottawa\, Canada\, Ottawa
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