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Practical Considerations for Implementing ICH Q14 for Each Drug Modality – Old and New
Roundtable 36 Notes: WCBP 2021
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Structure Function Studies of Non-standard mAb and Protein Therapeutics
Roundtable 34 Notes: WCBP 2021
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Multi-Attribute Method - Challenges in using MAM for QC of Therapeutic Proteins
Roundtable 33 Notes: WCBP 2021
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Visible and Sub-visible Particles: Practical Experiences in Manufacturing Support and Quality Control
Roundtable 32 Notes: WCBP 2021
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New Modalities and Technologies (other than CGTP)
Roundtable 31 Notes: WCBP 2021
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Analytics for Accelerated Products: Challenges and Opportunities
Roundtable 29 Notes: WCBP 2021
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Scaling Out: What Is It? What Are the Requirements?
Roundtable 28 Notes: WCBP 2021
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Best Practices for Working with CMOs for De-centralized Manufacturing
Roundtable 27 Notes: WCBP 2021
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Harmonization of Global Regulatory Submission Writing to Enable Acceleration
Roundtable 26 Notes: WCBP 2021
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Reference Standards for Cell & Gene Therapy Products - Best Practices for Autologous Therapies
Roundtable 25 Notes: WCBP 2021
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Adapting CMC Activities for Accelerated Approvals: Challenges and Lessons Learned, especially from Pandemics (Site Transfers, Scale Up, Comparability and Process Validation)
Roundtable 24 Notes: WCBP 2021
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Adapting CMC Activities for Accelerated Approvals - Challenges and Lessons Learned, especially from Pandemics (Stability, Specifications, Analytical Method Comparability)
Roundtable 23 Notes: WCBP 2021
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Vaccine Potency Assays
Roundtable 22 Notes: WCBP 2021
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Raw Materials Procurement Challenges: Lessons from the Pandemic
Roundtable 21 Notes: WCBP 2021
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Streamlining Shipping Qualifications / Transportation Validation
Roundtable 19 Notes: WCBP 2021
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Design of Stability Studies for Accelerated Product Development
Roundtable 18 Notes: WCBP 2021
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Next Generation Control Strategies: QTPP Definition and Implementation, CQA Definition and Setting Specifications Beyond Clinical Experience
Roundtable 17 Notes: WCBP 2021
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Surfactants: Control, Use, and Characterization
Roundtable 16 Notes: WCBP 2021
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Comparability Concepts and Case Studies
Roundtable 14 Notes: WCBP 2021
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ICHQ12 Regulatory Tools and Enablers: Lessons Learned
Roundtable 13 Notes: WCBP 2021