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Regulatory Updates: Harmonization of Biologics Regulation in the ECOWAS Region
Speaker Presentation Owusu Danso Patrick FDA 2018 -
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
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Development of a Vaccine Multi-Dose Vial: Rationale and Strategy
Speaker Presentation Warne Nick Pfizer, Inc. 2018
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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