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Reston, VA

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Online Registration is Open!
Register by Friday, July 24, 2015 to Save up to $400.
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FDA Presentations

Preview Past FDA Speaker Presentations

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

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

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Well Characterized Biologicals

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Novel Characterization Strategies and Regulatory Guidance to Ensure CMC Success

November 09-10, 2015 · Hyatt Regency Reston · Reston, 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
FDA/CDER/OPS

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

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