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Development of a Vaccine Multi-Dose Vial: Rationale and Strategy
Speaker Presentation Warne Nick Pfizer, Inc. 2018 -
An Overview of the Regulation of Biolotechnological and Biosimilar Products in Peru
Speaker Presentation Zavala Susan DIGEMID 2018
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CMC Strategy During the Accelerated Development of Brineura (cerliponase alfa)
Speaker Presentation Wilbur Linda BioMarin Pharmaceutical Inc. and Jacoby David BioMarin Pharmaceutical Inc. 2019
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Fast Test, Faster Results for Biosafety Testing: A Rapid Degenerate PCR & Fragment Analysis Sequencing Platform
Speaker Presentation Sohrabi Afshin BioReliance Corporation 2019
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Navigating the CMC and Regulatory Challenges of a Breakthrough Therapy Product for Multiple Myeloma
Speaker Presentation Schaefer Gene Janssen R&D, LLC 2019
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Leveraging Innovation to Improve Patient Access & Global Health
Speaker Presentation Robinson David The Bill & Melinda Gates Foundation 2019
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Process Science to Regulatory Science: Control Strategy and Established Conditions 2019
Speaker Presentation Robbins David MedImmune, A member of the AstraZeneca Group 2019
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Biologics in Brazil: Overview and Perspectives on Harmonization
Speaker Presentation Rama Elkiane ANVISA 2019
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Access-by-Design:
Making Biologics Available to All
Speaker Presentation Ram Rajeev MIT and Springs Stacy MIT 2019
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The Role of the Biological Laboratory in the Regulation of the Quality of Biological Products
Speaker Presentation Pines Gilia Israeli Ministry of Health 2019
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African Medicines Regulatory Harmonization - AMRH: Current Trends
Speaker Presentation Owusu-Danso Patrick Food and Drug Authority, Ghana 2019
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PMDA Updates with a Focus on GMP/CMC
Speaker Presentation Nakashima Nobu PMDA-Pharmaceuticals and Medical Devices Agency 2019
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Performance Based Approaches an Enabler
for Process Analytical Technology (PAT)
Speaker Presentation Moore Christine Merck & Co., Inc. 2019
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Health Canada’s Participation at ICH &Considering ICH-Q12 Implementation
Speaker Presentation Lourenco Celia Health Canada 2019
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Mapping Future Technology Needs and Prioritization of Critical Quality Attributes for Enabling In-Line Monitoring and Real Time Release Testing
Speaker Presentation Loladze Vaho GlaxoSmithKline 2019
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WHO Standards for Biotherapeutics: Tools for Regulatory Convergence
Speaker Presentation Knezevic Invana World Health Organization (WHO) 2019
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Improving Patient Access & Public Health: How Global Health Authorities and Industry can Collaborate on CMC Expectations
Speaker Presentation Karikari-Boateng Eric Food and Drug Authority, Ghana 2019
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An Advanced Process Control Framing to Application of Analytics and Modeling for Biopharm Manufacturing
Speaker Presentation Guenard Robert Biogen 2019
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Biosimilar Regulation in Israel
Speaker Presentation BenNaim Vered Israeli Ministry of Health 2019
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Unsupervised Machine Learning for Improved Understanding, Optimization, and Process Monitoring, Fault Diagnosis in Early Development
Speaker Presentation Afanador Nelson Merck & Co., Inc. 2019