Resources
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Moroccan Good Regulatory Practices: Regulatory and Technical Requirements for the Registration of Medicines for Human Use in Morocco
Speaker Presentation Lakhlili Wiame DMP 2020
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A Shared Framework for Protein Analytics; Bioassays Enhancing Drug Development
Speaker Presentation Kozlowski Steven CDER FDA 2020
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Curve Similarity Index for Testing Parallelism in Bioassay
Speaker Presentation Faya Paul Eli Lilly 2020
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Critical Reagents in Bioassay - Their Importance, Characterization and Storage
Speaker Presentation Asara Nana Charles River Laboratories 2020
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The USP Bioassay Chapters: Out with the Old, In with the New
Speaker Presentation Walfish Steven USP 2019
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Performing Bioassays - an OMCL Point-of-view
Speaker Presentation Vesterinen Jaana Finnish Medicines Agency 2019
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Bioassay Development for Complex Biologics: A Case Study for a Prodrug
Speaker Presentation Swiss Victoria Bristol-Myers Squibb 2019
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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