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| Join us! |
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| The United States Pharmacopeia (USP) will host a Biologics Stakeholder Forum on Friday, January 10, 2020 at the Omni San Francisco Hotel in San Francisco, CA from 9:00 a.m. - 5:00 p.m. |
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| The USP Biologics Stakeholder Forum provides a collaborative framework for representatives of biologics manufacturers, associations, regulators, and other groups to engage with USP on addressing challenges that occur throughout the development lifecycle that relate to quality standards, tools, and training. The Forum also serves as a venue for USP staff and volunteers to inform USP Biologics stakeholders of USP initiatives, work in progress, and opportunities to support development of new standards. |
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| Objectives |
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Educate stakeholders on the current USP Biologics’ strategy and learn about standards in development |
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Gather subject matter experts on multi-attribute monitoring (MAM) and to hear case studies about its use in characterization of biologics and opportunities for release testing |
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Discuss challenges around implementing these approaches in a GMP environment and identify standards that might support these innovative approaches supporting quality and efficient testing |
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| Who Should Participate? |
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| Subject matter experts in MAM, Biologics manufacturers, contract research organizations, regulators, and suppliers, whether members of a trade organization or independent. |
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