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Disruptive Micro-Facility for Affordable Vaccines Manufacturing
Speaker Presentation Damien Benjamin Univercells 2018 -
Testing the Quality of Medicines in the Field
Speaker Presentation Desai Darash Boston University 2018
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Vision to Global Pharmacopeia: Convergence and Upcoming Development of Biological Chapters in Chinese Pharmacopoeia
Speaker Presentation Guo Zhong ping Chinese Pharmacopoeia Commission 2018
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A New Paradigm for Translational Vaccine Development
Speaker Presentation Heaton Penny Gates Medical Research Institute 2018
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Transforming Biopharmaceutical Production Through the Deployment of Continuous Manufacturing Technologies
Speaker Presentation Hewig Art Amgen Inc. 2018
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International Pathways for Accelerated Development: Lessons Learned
Speaker Presentation Keane Richard Biogen 2018
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Analytical Characterization of Dolaflexin-ADCs
Speaker Presentation Lee David Mersana 2018
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Vaccine Development and Licensure Pathways: An Emerging Infectious Disease Vaccine Example
Speaker Presentation Levis Robin CBER, FDA 2018
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Using Structure/Function Relationships to Identify CQAs and Develop Analytical Specifications
Speaker Presentation Lewis Mike Janssen 2018
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Reform of Biological Products Review with a Focus on CMC
Speaker Presentation Li Min Center CFDA 2018
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Amgen's Attribute Based Control Strategies
Speaker Presentation Monica Tom Amgen Inc. 2018
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PMDA Updates
Speaker Presentation Nakamura Takahiro PMDA 2018
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Technical and Regulatory Aspects of Pharmaceutical Product Lifecycle Management: ICH Q12
Speaker Presentation Nasr Moheb PhRMA ICH 2018
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Regulatory Updates: Harmonization of Biologics Regulation in the ECOWAS Region
Speaker Presentation Owusu Danso Patrick FDA 2018
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WCBP 2018 ICH WorkshopHealth Canada Challenges & Opportunities
Speaker Presentation Parker Cathy Health Canada 2018
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Regulatory ICH Countries: Current Harmonization Challenges and Future Opportunities
Speaker Presentation Richardson Peter European Medicines Agency 2018
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Considerations While Setting Specifications for Vaccines
Speaker Presentation Rohlfing Paul Pfizer, Inc. 2018
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Critical Quality Attributes Pertaining to
Immunogenicity: A Preponderance of
Evidence Approach to Control Strategies
Speaker Presentation Rosenberg Amy CDER, FDA 2018
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Biosimilar Clinical Evaluation: ANMAT Process and Perspective
Speaker Presentation Saidman Claudia ANMAT 2018
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An FDA Perspective on the Implementation of State-of-the-Art Analytical Methods for the Development of Therapeutic Proteins
Speaker Presentation Shapiro Marjie FDA 2018