The 16th annual CMC Strategy Forum Europe, organized by CASSS, will explore many critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products. The series of workshops, led by experts from global regulatory agencies, industry and academia, will seek to explore emerging aspects of CMC technology and regulation in areas where existing modalities and systems are undergoing change. Topics will include: M4Q & Digital Regulatory Assessment, New Technologies for Analytical Control (Multi-attribute Methodology, HCP-MS...), The Acceptance of Modelling Approaches, Innovation for Products and Processes, Efficiency Toolbox: Development and Lifecycle Management, as well as the EFPIA MQEG Biomanufacturing Satellite Session that will include concept paper updates and a scientific session on the Conversion of IV to SubQ Application.
The CMC Strategy Forum is designed to maximize dialog between participants. Presentations are relatively short and focused and set the agenda for the panel discussions to engage all the participants who have experience and expertise to share. It should be important for you to attend this event as we come together to discuss important issues on how to ensure product safety and efficacy for the patients we serve.
We would like to thank the speakers and panel members who are giving generously of their time and resources, and to you, for your attendance.
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The scientific organizing committee gratefully acknowledges the following program partners for their generous support of CMC Europe 2022.