Well Characterized Biologics & Biological Assays

27 - 29 Oct 2020
College Park Marriott Hotel & Conference Center, Washington DC, USA

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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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100 - 500
Based on previous editions

Category & Type

Medical & Pharma
Science & Research


27 - 29 Oct 2020 Interested
11 - 13 Nov 2019

Frequency Annual

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User Community [ Users who have shown interest for this Event ]

GoingSeulgi Park

Seulgi Park

Associate Researcher at GC Pharma

Yongin-si, South Korea
Vanessa C Grubbs

Vanessa C Grubbs

Documentation Manager at Leidos Biomedical Research, Inc.

Walkersville, United States
Meng Zhang

Meng Zhang

Analytical R&D at GSK

Rockville, United States


Engineer at Azzur Group

Washington DC, United States

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College Park Marriott Hotel & Conference Center

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

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