Well Characterized Biologics & Biological Assays

25 - 28 Oct 2021
Virtual Event
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"Ensure CMC Success and Expedite Your Product's Path to Market by Optimizing Characterization Strategies and CMC Bioassay Development"
Well Characterized Biologics & Biological Assays is a platform to gain practical advice from case studies, FDA & regulatory leaders to accelerate your biologics & novel modalities/molecules to market. Each year, this meeting brings in FDA speakers from CBER/CDER that is onsite with a big presence. They'll be able to answer all of your regulatory questions and present on some key topic areas of interest. We're finalizing the representatives that are coming. In the meantime, here are some potential topic areas that will be addressed Regulatory Guidelines on Analytical Procedure Validation vs. Qualification, Regulatory Updates and Insights on Emerging Technologies for Analytical and Bioassay Development, and Most Problematic Areas of Submissions for Analytical Characterization and Bioassay Development.


09:00 AM-06:00 PM (expected)
Not Verified

Entry Fees

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Estimated Turnout

100 - 500
Based on previous editions

Category & Type

Medical & Pharma
Science & Research


Oct 2021 Interested
+2 more editions

Frequency Annual

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