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Conference

Well Characterized Biologics & Biological Assays

01 - 02 Nov 2022 New Date Reminder
College Park Marriott Hotel & Conference Center, Washington DC, USAGet Directions
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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.


Timings

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

Entry Fees

Check Official Website

Estimated Turnout

500 - 1000
Delegates
Based on previous editions

Category & Type

Conference
Medical & Pharma
IT & Technology

Editions

Nov 2022
+3 more editions

Frequency Annual
Next edition likely in Nov 2023

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3501 University Blvd E, Hyattsville, MD 20783
Washington DC, USA

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