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Transforming Global Regulatory CMC Practices

Image of purple background with text 'WCBP' "Transforming Global Regulatory CMC Practices in an Age of Revolutionary Innovation" features a panel of esteemed regulatory experts, including representatives from ANVISA, US FDA, EMA, PMDA, and WHO, who share their invaluable insights on global harmonization. View the Plenary Session

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CMC Strategy Forum (11)

CMC Strategies for Expedited Program Development — Regulatory Perspectives

CMC Summary Paper: CMC Strategy Forum North America Fall 2020
Phase Appropriate Expectations for Analytical Methods and Process Validation for Expedited Programs: A Regulatory Perspective

Speaker Presentation Powdrill Megan, Health Canada, 2020
Merck's Approaches and Challenges for Implementation of Phase-Appropriate GMP Continuum

Speaker Presentation Mabe Todd, Akouos Inc., 2020
Validation and Implementation of an Automated Colony Counter for Product Testing in Biopharmaceutical Manufacturing

Speaker Presentation Deutschmann Sven, Roche Siagnostics GmbH, 2020
Expedited Programs: Phase Appropriate Regulatory Expectations for Microbial Control and Sterility Assurance

Speaker Presentation Hughes Patricia, CDER, FDA, 2020
Taking Stability Off the Critical Path of Product Development

Speaker Presentation Lennard Andrew, Amgen Limited, 2020
Specific Regulatory Strategies for Process Validation for Biologics

Speaker Presentation Wilkinson Diane, AstraZeneca, 2020
Commercial Process Control Strategy Considerations for Cell Therapy Products

Speaker Presentation Rajendran Saravanamoorthy, Bristol-Myers Squibb Company, 2020
Regulatory Approaches for Accelerated Development in Europe

Speaker Presentation Welin Mats, Swedish Medical Products Agency, 2020
Pandemic Preparedness: Regulatory Agility in the Era of COVID-19

Speaker Presentation Fernandes Jason, Health Canada, 2020
Vaccine Development and Licensure Pathways: An Emerging Infectious Disease Vaccine Example

Speaker Presentation Levis Robin, CBER, FDA, 2020
Expedited Programs and Challenges to Biologics Manufacturing

Speaker Presentation Kirshner Susan, CDER, FDA, 2020