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Strategies for Setting Phase Appropriate Endotoxin Specifications
Roundtable 29 Notes: WCBP 2022
New Advances and Applications in Real Time Release Testing
Roundtable 27 Notes: WCBP 2022
Nitrosamine Risk Assessments – Implementation
Roundtable 26 Notes: WCBP 2022
To Outsource (That Test) or Not to Outsource – That Is the Question! (Analytical Testing)
Roundtable 24 Notes: WCBP 2022
Modernizing Stability ICH Guidance, Including Science and Risk-Based Approaches to Encompass Biologics and New Modalities
Roundtable 23 Notes: WCBP 2022
Big Data Applications in Biopharmaceutical Process and Product Development
Roundtable 22 Notes: WCBP 2022
Setting Specifications on Limited Data, Clinically Relevant Specs
Roundtable 21 Notes: WCBP 2022
Considerations for Introducing Novel Excipients in DP Formulations, Across All Modalities
Roundtable 20 Notes: WCBP 2022
Regulator Review Preferences and Recent Review Trends - Questions, Key Issues
Roundtable 18 Notes: WCBP 2022
Opportunities for Engagement and Collaboration to Achieve Stakeholder Alignment on Closed System Transfer Devices (CSTDs)
Roundtable 17 Notes: WCBP 2022
Intra-Site and Inter-Site Transfer of Analytical Methods for the Biopharmaceutical Products - Approach and Namely Regulatory Experiences
Roundtable 16 Notes: WCBP 2022
Method Selection and Acceptance Criteria to Support In-Use Stability and Compatibility Studies
Roundtable 15 Notes: WCBP 2022
Academic Connections and Collaborations to Accelerate Drug Development
Roundtable 14 Notes: WCBP 2022
Global Filings, In-Country Testing Challenges and Solutions
Roundtable 12 Notes: WCBP 2022
Comparability – Few Batches, Stability, Shelf Life
Roundtable 5 Notes: WCBP 2022
Platform Approaches for Control Strategies in Submissions
Roundtable 1 Notes: WCBP 2022
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
Modernizing Regulations in the Context of COVID-19 in Canada
Speaker Presentation Turpin Jason, Health Canada, 2021
From Benchtop to Approval in Record Time A Case Study of Ronapreve
Speaker Presentation Shameem Mohammed, Regeneron Pharmaceuticals, Inc., 2021
ICH Q13 Update: Continuous Manufacturing of Drug Substances and Drug Products
Speaker Presentation Sakurai Kyoko, PMDA, 2021