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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.
Timings09:00 AM-06:00 PM (expected)
Entry FeesCheck Official Website
Estimated Turnout100 - 500
DelegatesBased on previous editions
Category & TypeConference
Medical & Pharma
Science & Research
EditionsOct 2021 Interested
+2 more editions
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OrganizerSend Stall Book Request
Informa Markets - Boulder, USATop RatedUSA293 Total Events / 84 Upcoming Events277+ Followers