Resources
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Considerations for Introducing Novel Excipients in DP Formulations, Across All Modalities
Roundtable 20 Notes: WCBP 2022
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Regulator Review Preferences and Recent Review Trends - Questions, Key Issues
Roundtable 18 Notes: WCBP 2022
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Opportunities for Engagement and Collaboration to Achieve Stakeholder Alignment on Closed System Transfer Devices (CSTDs)
Roundtable 17 Notes: WCBP 2022
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Intra-Site and Inter-Site Transfer of Analytical Methods for the Biopharmaceutical Products - Approach and Namely Regulatory Experiences
Roundtable 16 Notes: WCBP 2022
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Method Selection and Acceptance Criteria to Support In-Use Stability and Compatibility Studies
Roundtable 15 Notes: WCBP 2022
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Academic Connections and Collaborations to Accelerate Drug Development
Roundtable 14 Notes: WCBP 2022
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Global Filings, In-Country Testing Challenges and Solutions
Roundtable 12 Notes: WCBP 2022
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Comparability – Few Batches, Stability, Shelf Life
Roundtable 5 Notes: WCBP 2022
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Unconscious Bias - Diversity, Equity, and Inclusion: What Is Working, Where Can We Do Better?
Roundtable 2 Notes: WCBP 2022
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Platform Approaches for Control Strategies in Submissions
Roundtable 1 Notes: WCBP 2022
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From Benchtop to Approval in Record Time: A Case Study of Ronapreve Part 2
Speaker Presentation Willcockson Maren, Genentech, a Member of the Roche Group, 2021
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Modernizing Regulations in the Context of COVID-19 in Canada
Speaker Presentation Turpin Jason, Health Canada, 2021
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From Benchtop to Approval in Record Time A Case Study of Ronapreve
Speaker Presentation Shameem Mohammed, Regeneron Pharmaceuticals, Inc., 2021
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ICH Q13 Update: Continuous Manufacturing of Drug Substances and Drug Products
Speaker Presentation Sakurai Kyoko, PMDA, 2021
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Regulating Vaccines During COVID-19
Speaker Presentation Overking Cassandra, CBER, FDA, 2021
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PMDA Perspective: Recent Trends in the
Regulation of Biopharmaceuticals
Speaker Presentation Naruse Ryoko, PMDA, 2021
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Regulatory Flexibilities in CMC Review on Vaccines under the COVID-19 Pandemic
Speaker Presentation Mitsuki Motoaki, PMDA, 2021
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COVID Vaccine Development Strategies, Challenges and Lessons Learned Regulatory CMC Perspective
Speaker Presentation Kavanaugh Nancy, AstraZeneca, 2021
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CMC Strategy Forum Japan 2021 Welcome and Introductory Comments
Speaker Presentation Arai Hiroyuki, PMDA, 2021
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Creating CMC Strategies for Pandemics and Beyond
CMC Summary Paper: WCBP 2021 Special Edition