Papers and Presentations
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Advantages and Challenges of Working with Non-ICH Countries
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/wcbp/2023/wcbp2023_120x120_landing593821b0-7ff0-444d-b8da-38a4481654c2.jpg?sfvrsn=40f36ee0_1)
Speaker Presentation Thanaphollert Prapassorn FDA 2018 -
Conundrums in Biotechnology: How Does Quality Impact Safety?
Speaker Presentation Alexander G Caleb Johns Hopkins School of Public Health 2018
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Overview of Regulatory Trends in Biological Products
Speaker Presentation Bai He China Food and Drug Administration 2018
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Assessment Framework of Israel
Speaker Presentation Ben Naim Vered Israel Ministry of Health 2018
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ICH Implementation at ANVISA
Speaker Presentation Bernardes Floreno Monica ANVISA 2018
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FDA High-Level Update
Speaker Presentation Brunelle Joslyn FDA 2018
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Development of Control Strategy for Vaccine Products
Speaker Presentation Campa Cristiana GlaxoSmithKline 2018
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A Potential Innovative CMC Solution: Responding To Public Health Needs With An Accelerated Clinical Pathway–A Vaccine Example
Speaker Presentation Christian Natalie Merck, Co. Inc. 2018
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A Regulatory Perspective on Integrated Control Strategy for Therapeutic Proteins
Speaker Presentation Damdinsuren Bazarrahchaa CDER, FDA 2018
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Disruptive Micro-Facility for Affordable Vaccines Manufacturing
Speaker Presentation Damien Benjamin Univercells 2018
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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