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Role of Cryo-TEM as an Orthogonal Method to Help Assess Formulation Purity, Potency for Nanoparticles
Roundtable 16 Notes: WCBP 2024
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Regulatory Expectations and Challenges: Lessons Learned from Developing Countries
Roundtable 12 Notes: WCBP 2024
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Regulatory Considerations and Experiences for Control Strategies in Different Regions - Focus on General Challenges with Divergence
Roundtable 6 Notes: WCBP 2024
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Regulatory Considerations and Experiences for Control Strategies in Different Regions
Roundtable 6 Notes: WCBP 2024
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Regulator Review Preferences and Recent Review Trends: Questions and Key Issues - Focus on US FDA
Roundtable 4 Notes: WCBP 2024
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Regulator Review Preferences and Recent Review Trends - Questions and Key Issues - Focus on Ex-US Regions
Roundtable 4 Notes: WCBP 2024
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Recent Experiences with Regulation of Biosimilars at the FDA
Roundtable 15 Notes: WCBP 2024
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Raw Material and Critical Reagent Control Strategies - Post Approval Challenges Including Shortages
Roundtable 16 Notes: WCBP 2024
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Potency Assays - Use of Structure Function Models - MOA - Replace Biological - Cell-based Assays - Replacing in-vivo with in-vitro Potency Assays
Roundtable 5 Notes: WCBP 2024
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NMR in Extended Characterization of Biologics
Roundtable 17 Notes: WCBP 2024
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New Analytical Technologies Being Implemented in GMP Product Testing and Manufacturing – Focus on Regulatory Challenges
Roundtable 7 Notes: WCBP 2024
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Navigating the Complexities of EU EMA Annex 1 Overcoming Challenges in Sterile Pharmaceutical Manufacturing
Roundtable 20 Notes: WCBP 2024
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In Use Stability and Compatibility Testing: Microbial Challenge Studies and Requirements
Roundtable 11 Notes: WCBP 2024
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ICH Q12- Global Implementation Challenges With PACMPs and Established Conditions
Roundtable 11 Notes: WCBP 2024
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How Instrument Lifecycle Practices Can Facilitate the Best Technology While Ensuring Quality
Roundtable 7 Notes: WCBP 2024
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Focus on FDA's Plans for Advanced Manufacturing and Platform Technology Designations
Roundtable 14 Notes: WCBP 2024
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Extractables and Leachables - New ICH Q3E Guidance, Common Practices and Challenges
Roundtable 19 Notes: WCBP 2024
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Continuous Manufacturing - Continued Implementation of ICH Q13 Worldwide
Roundtable 10 Notes: WCBP 2024
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Comparability Approaches in Development and Beyond - Focus on Traditional Biotherapeutics
Roundtable 3 Notes: WCBP 2024
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Comparability Approaches - Focus on Cell and Gene Therapies (see FDA draft guidance)
Roundtable 18 Notes: WCBP 2024