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WHO Standards for Biotherapeutics: Tools for Regulatory Convergence
Speaker Presentation Knezevic Invana World Health Organization (WHO) 2019 -
Improving Patient Access & Public Health: How Global Health Authorities and Industry can Collaborate on CMC Expectations
Speaker Presentation Karikari-Boateng Eric Food and Drug Authority, Ghana 2019
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An Advanced Process Control Framing to Application of Analytics and Modeling for Biopharm Manufacturing
Speaker Presentation Guenard Robert Biogen 2019
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Biosimilar Regulation in Israel
Speaker Presentation BenNaim Vered Israeli Ministry of Health 2019
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Unsupervised Machine Learning for Improved Understanding, Optimization, and Process Monitoring, Fault Diagnosis in Early Development
Speaker Presentation Afanador Nelson Merck & Co., Inc. 2019
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Extractables and Leachables- What’s Being Requested and What’s Everyone Doing?
Roundtable 29 Notes: WCBP 2020
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Formulation Development
Roundtable 28 Notes: WCBP 2020
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Shipping Studies – Analytical Strategies
Roundtable 27 Notes: WCBP 2020
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Data Integrity
Roundtable 26 Notes: WCBP 2020
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The Multi-Attribute Method: Best Practices for Continued Success
Roundtable 25 Notes: WCBP 2020
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Advanced Technologies
Roundtable 24 Notes: WCBP 2020
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Bispecific Antibody
Roundtable 23 Notes: WCBP 2020
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New Challenges for an Old Problem: Tales of Subvisible Particles
Roundtable 22 Notes: WCBP 2020
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Vaccines: Potency Assays – What’s Love Got to Do with It?
Roundtable 21 Notes: WCBP 2020
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Trace Metals
Roundtable 20 Notes: WCBP 2020
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Is There a Problem Using Closed System Transfer Devices with Biological Products?
Roundtable 19 Notes: WCBP 2020
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NDA to BLA/Biosimilar – Are You Ready for the New Grey Zone?
Roundtable 18 Notes: WCBP 2020
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Visual Inspection
Roundtable 17 Notes: WCBP 2020
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Endotoxin Testing
Roundtable 16 Notes: WCBP 2020
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Viral Clearance- Analytical Strategies
Roundtable 15 Notes: WCBP 2020