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5th USP Workshop on Therapeutic Peptides |
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Join thought leaders from industry, academia and regulatory agencies to discuss emerging topics that impact the therapeutic peptides community on November 5-6, 2018 at the USP Meetings Center in Rockville, MD. Hear from the U.S. FDA about regulatory considerations including FDA guidance after public comments. |
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Sessions will cover: |
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Transitions from recombinant to synthetic peptides and new CMC expectations from US and EU regulatory agencies |
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New strategies and novel technologies to appropriately characterize therapeutic peptides Bioassays as part of control strategies for large, complex peptides |
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Novel formulation strategies for synthetic peptides |
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The impact of aggregation of peptides and potential immunogenicity concerns See the complete agenda and register to participate in discussions that will impact the quality of these medicines and the biotherapeutics industry.
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