Resources
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M4Q(R2) - An Industry Perspective
Speaker Presentation Pope Miksinski Sarah AstraZeneca 2022
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Efficiency Toolbox - CMC Lessons Learned from COVID
Speaker Presentation Pellet Mark AstraZeneca 2022
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Continuous Manufacturing in Biologics Adoption and Regulatory Engagement
Speaker Presentation Nita Ana Silvia MSD 2022
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CMC Aspects When Switching from Intravenous to Subcutaneous Formulations
Speaker Presentation Mayer Christian AGES MEA 2022
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FDA Perspective on Opportunities for Modernization of Regulatory Submissions
Speaker Presentation Markovic Ingrid CBER, FDA 2022
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Using Stability Prior Knowledge From 'Like-molecules' to Determine Shelf-life
Speaker Presentation Lennard Andrew Amgen Ltd 2022
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A Personal Perspective on the Use of Models in Module 3
Speaker Presentation Lee Nick HPRA-Health Products Regulatory Authority 2022
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Setting Acceptance Criteria for Release Specification Based on Limited Batch Data
Speaker Presentation Kirke David BioMarin UK Ltd 2022
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Novel HCP Analysis and Characterisation Tools Provides Freedom of Operation for Efficient Process Development
Speaker Presentation Kåre Kristensen Brian Novo Nordisk 2022
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How to Leverage Pharmaceutical Development and Manufacturing Data for Marketing Authorisations - EMA's Perspective
Speaker Presentation Jekerle Veronika EMA 2022
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Modelling of Subcutaneous Injection & Bioavailability to Bridge IV/SubQ
Speaker Presentation Gresham Joel Crux 2022
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Regulatory Considerations for the Application of Multi-Attribute Methods by Mass Spectrometry for QC Release and Stability Testing of Biopharmaceuticals
Speaker Presentation Gervais Annick UCB_EFPIA 2022
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A Roadmap to Get Host Cells Proteins Analysis by Mass Spectrometry in a GMP Environment
Speaker Presentation Chéry Cyrille UCB 2022
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Enhanced Process Characterization Study with Monte-Carlo Simulation
Speaker Presentation Broly Hervé Merck Serrano 2022
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Support to Innovation by EMA - Facilitating Translation of Technology into Medicinal Products
Speaker Presentation Bream Robert EMA 2022
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Establishing Platform Technology Master Files for Human Medicinal Products in the EU/EEA
Speaker Presentation Bilanin Mihai GSK 2022
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Agile Manufacturing -Transfer and Scale-up of Biologics Aseptic Manufacturing Processes through Control Site Concept
Speaker Presentation Bechtold-Peters Karoline Novartis Pharma AG 2022
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Immunogenicity or Not of Biologics in the Subcutaneous Space
Speaker Presentation Balu-Iyer Sathy SUNY, Univeristy of Buffalo 2022
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Industry Proposal For The Use Of QBD And ICH Q12 Principles To Enable Second Sourcing Of Raw Materials
Speaker Presentation Aiyer Kavita Seagen Inc. 2022
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The Power of Data Exchange, CMC Interoperability and a Cloud-based Ecosystem
Speaker Presentation Abernathy Michael Amgen Inc Accumulus Synergy 2022