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WCBP 2018: Roundtable Information
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Roundtable Session 1: Tuesday, January 30, 16:00 - 17:00


 

               
 

   Spotlight Topic: From PPQ Batches to Product Licensure - Continuous Process Improvement

 

   Table 1: Evolution of CQAs Throughout a Program Lifecycle

 

   Table 2: New Mechanisms for DS Process Control

 

   Table 3:  Visible Particles: Just Another Critical Quality Attribute

 

    Table 4: PAI Inspections (including Mutual Inspection Experiences)

 

   Table 5: Replacing In Vivo with In Vitro Potency Assasy

 

   Table 6: Immunogenicity and Regulator's Current Expectations

 

   Table 7: QbD Implementation: Learning from the Past to Shape the Future

 

   Table 8: Biosimilarity Assessment

 

   Table 9: Lifecycle Considerations for Bridging Analytical Methods

 

   Table 10: ADC's mAb or DS: Characterization and Comparability

 

   Table 11: Frozen Stability: To Test or Not to Test

 

   Table 12: Stability Testing of Biologics - New USP Chapter

 

   Table 13: Early Specs for Tox and FIH

 

   Table 14: In-country Manufacturing to Enable Lower Cost Medicines in Developing Countries

 

   Table 15: Lifecycle Management: Risk Assessments

 

   Table 16: Control Strategies IPCs/PAT

 

   Table 17: Shipping Qualification

 

   Table 18: Characterization Assays for Early Product Development

 

   Table 19: Quality or Regulatory Submission: New Items in  Regulatory Filings?

 

   Table 20: Glycan Comparability Between Processes

 

   Table 21: Phase Appropriate Control Strategy for Host Cell Protein

 

   Table 22: Forced Degradation

 

   Table 23: Surfactants: Control, Use , and Characterization

 

   Table 24: Rare Disease-specific and Expedited Review Regulations in Emerging Markets

 

   Table 25: Pool for Tox…Pool for Ph1 GMP?

 

 


Roundtable Session 2: Wednesday, January 31, 12:15 - 13:15



 

Spotlight Topic: Reference Standard Management

    
    Table 1: Evolution of CQAs Throughout a Program Lifecycle

 

   Table 2: Patient Centric Drug Development

 

   Table 3: Visible Particles: Just Another Critical Quality Attribute

 

   Table 4: PAI iIspections (including Mutual Inspection Experiences)

 

   Table 5: ID Testing from Incoming DS to FPID. Technical Approaches and Regulatory Requirements

 

   Table 6: Immunogenicity and Regulator's Current Expectations

 

   Table 7: Surfactants: Control, Use , and Characterization

 

   Table 8: In-country Manufacturing to Enable Lower Cost Medicines in Developing Countries

 

   Table 9: Validation of Release Assay for Aggregates Measurement

 

   Table 10: ADC's mAb or DS: Characterization and Comparability

 

   Table 11: Lean Control Systems for Biotech Products. Possibilities and Limitations

 

   Table 12: Stability Testing of Biologics - New USP Chapter

 

   Table 13: Risk Assessments to Address Differing Global Requirements

 

   Table 14: Data Integrity: Harmonizing Regulatory Requirements with Current and Emerging Technology

 

   Table 15: Clinical Support of Specifications for Vaccines

 

   Table 16: LER: Status of Industry and Regulatory Approaches

 

   Table 17: Data Management in the 21st Century

 

   Table 18: Use of Crystal Structure-modelling Approach for CQA Assessment, Bioassay Design and Troubleshooting

 

   Table 19: Quality or Regulatory Submission: New Items in  Regulatory Filings?

 

   Table 20: Opportunities and Roadblocks to Global Access to Biopharmaceuticals

 

   Table 21: Synergism of Combination Product.  Need to Monitor or Not?

 

   Table 22: How will Global Isolationism Affect the Biopharmaceutical Industry

 

   Table 23: ICH Guidelines for UV, etc

 

   Table 24: Global Strategies for Implementing QC Automation Post Approval

 

   Table 25: Pool for Tox…Pool for Ph1 GMP?

 

    


 

 

 

more Calendar

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AT Europe 2018

4/9/2018 » 4/11/2018
HOS 2018

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