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Microbial Challenge In-use Studies - Industry efforts to harmonize strategies in collaboration with Health Authorities
Speaker Presentation Leiske Seagen Inc. Zamiri Genentech 2022
Use of Stability Modeling to Support Accelerated Biologicals and Vaccines Development and Real-Time Stability Supply
Speaker Presentation Clénet Didier Sanofi Pasteur 2022
Regulator Review Preferences and Recent Review Trends - Questions, Key Issues - 2
Roundtable 40 Notes: WCBP 2022
Method Selection and Acceptance Criteria to Support In-Use Stability and Compatibility Studies - 2
Roundtable 37 Notes: WCBP 2022
mRNA - Vaccines and Beyond
Roundtable 34 Notes: WCBP 2022
Acceleration and CMC - Novel Approaches to Enabling Acceleration
Roundtable 31 Notes: WCBP 2022
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