Advancing Biomanufacturing and Global Regulatory Modernization

The 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.

The 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.

A 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

ess to biologic therapies.

Participants 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.

Click this link to open the scientific program in a new tab. View the full Forum abstract below