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New Modalities and Technologies (other than CGTP)
Roundtable 31 Notes: WCBP 2021
Analytics for Accelerated Products: Challenges and Opportunities
Roundtable 29 Notes: WCBP 2021
Scaling Out: What Is It? What Are the Requirements?
Roundtable 28 Notes: WCBP 2021
Best Practices for Working with CMOs for De-centralized Manufacturing
Roundtable 27 Notes: WCBP 2021
Harmonization of Global Regulatory Submission Writing to Enable Acceleration
Roundtable 26 Notes: WCBP 2021
Reference Standards for Cell & Gene Therapy Products - Best Practices for Autologous Therapies
Roundtable 25 Notes: WCBP 2021
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
Adapting CMC Activities for Accelerated Approvals - Challenges and Lessons Learned, especially from Pandemics (Stability, Specifications, Analytical Method Comparability)
Roundtable 23 Notes: WCBP 2021
Vaccine Potency Assays
Roundtable 22 Notes: WCBP 2021
Raw Materials Procurement Challenges: Lessons from the Pandemic
Roundtable 21 Notes: WCBP 2021
Streamlining Shipping Qualifications / Transportation Validation
Roundtable 19 Notes: WCBP 2021
Design of Stability Studies for Accelerated Product Development
Roundtable 18 Notes: WCBP 2021
Next Generation Control Strategies: QTPP Definition and Implementation, CQA Definition and Setting Specifications Beyond Clinical Experience
Roundtable 17 Notes: WCBP 2021
Surfactants: Control, Use, and Characterization
Roundtable 16 Notes: WCBP 2021
Comparability Concepts and Case Studies
Roundtable 14 Notes: WCBP 2021
ICHQ12 Regulatory Tools and Enablers: Lessons Learned
Roundtable 13 Notes: WCBP 2021
Low Endotoxin Recovery (LER)
Roundtable 12 Notes: WCBP 2021
Forced Degradation Studies - Best Practices. What, When, How, Where and Why?
Roundtable 11 Notes: WCBP 2021
Technical Transfer of Analytical Procedures - Best Practices, Pitfalls and Regulatory Considerations
Roundtable 9 Notes: WCBP 2021
Reference Standards - Common Practices and Challenges
Roundtable 8 Notes: WCBP 2021