Resources
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Bioassays: the Italian OMCL Experience
Speaker Presentation Luciani Francesca Istituto Superiore di Sanità 2019
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Postcards from the Edge: Regulatory Reflections
Speaker Presentation Kirshner Susan US FDA 2019
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Analytical Methods for Vaccines: FDA Perspective
Speaker Presentation Gagneten Sara CBER FDA 2019
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Automation of Potency Assays: it’s not plug‐and‐play, it’s a journey
Speaker Presentation Beck Hermann Roche 2019
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Bioassays for Cell and Gene Therapy Products: A Canadian Regulatory Perspective and Experience
Speaker Presentation Storbeck Chris Health Canada 2018
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3 in 1: Increasing Efficiency of Potency Assay Optimization via DoE
Speaker Presentation Solzin Johannes Boehringer Ingelheim 2018
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Understanding Mechanisms of Action and Structure‐Function Relationships: A Regulator’s Perspective
Speaker Presentation Shapiro Marjie CDER FDA 2018
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Coagulation Factor Products: Potency Determination and Related Complications
Speaker Presentation Ovanesov Mikhail US FDA 2018
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System and Sample Suitability Assessment for Potency Methods
Speaker Presentation Li Ruojia Bristol-Myers Squibb 2018
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Successful Analyst Assay Training and Assay Transfers- Basics and Recommendations to Achieve These Goals
Speaker Presentation Knorre Alex Eurofins 2018
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An MHRA Perspective on Bioassays
Speaker Presentation Both Leonard MHRA 2018
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Minimization of Bioassay Test Result Shift When Implementing New Reference Standard Batches
Speaker Presentation Borer Matthew Eli Lilly 2018
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Setting and Revision of Specifications - Regulatory Considerations/expectations; New Challenges, Interplay Between Analytical Test Results, Clinical Testing and Regulatory Expectations (Identification of CQAs)
Roundtable 6 Notes: AT Europe 2022
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Why and How to Move New Analytical Technologies from R&D to GMP
Roundtable 5 Notes: AT Europe 2022
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New Developments in Analytical Methods for Novel Modalities and PAT
Roundtable 4 Notes: AT Europe 2022
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ICH Q2(R2) / ICH Q14
Roundtable 3 Notes: AT Europe 2022
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Stability
Roundtable 2 Notes: AT Europe 2022
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Vaccines – Analytical Platform Technology
Roundtable 1 Notes: AT Europe 2022
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3D Structure of Biologics in a Convenient Immunoassay Format
Speaker Presentation Wang Xing Array Bridge 2017
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Challenges with Equivalence Testing According to USP <1032>
Speaker Presentation Stegmann Ralf Stegmann Systems 2017