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Well Characterized Biologicals


Ensure CMC Success through Novel Characterization Strategies and Regulatory Guidance

November 03-04, 2016 · The Westin Arlington Gateway · Arlington, VA

FDA Presentation Download

FDA Presentation Download

Preview FDA Presentations Presented at Past Well Characterized Biologicals meetings

Thank you for your interest in IBC's Well Characterized Biologicals. To give you sneak peek at the caliber of the content presented at the conference - we would like to give you FREE access to a few of our past FDA speaker presentations.

Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies

Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry

Simply complete the below form and you will then be able to download the above presentations (PDF).
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