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Unearth the Real Value of Your Complex Biopharma Analytical Data Through a Powerful Enterprise Software Platform
Speaker Presentation Pre-Record Vendor Showcase Presented by Protein Metrics 2023 -
ICH Q14 & Related Regulatory Aspects
Speaker Presentation Parvin Most CBER,FDA 2023
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Update on ICH M4Q(R2) and Industry perspective
Speaker Presentation Nielsen Henrik Kim Novo Nordisk 2023
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Win, Lose or Draw - The ICH Q12 Experience from the Industry Perspective
Speaker Presentation Luu Minh Genentech, a Member of the Roche Group 2023
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Harnessing the Invaluable Tribal Knowledge Hidden in Your Organization
Speaker Presentation Lipa Martin Merck and Co., Inc. 2023
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Regulatory Considerations for Keeping Things Moving
Speaker Presentation Levis Robin CBER, FDA 2023
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Implementation of Novel Strategies and Novel Technologies for Acceleration of IND and BLA Submissions
Speaker Presentation Implementation of Novel Strategies and Novel Technologies for Acceleration of IND and BLA Submissions Mini Case 2023
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Implementation of ICH Q12: Successes and Challenges
Speaker Presentation Implementation of ICH Q12 Successes and Challenges Workshop 2023
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FDA/CDER Perspectives on Analytical Procedure Development and Validation
Speaker Presentation Hsu Amy CDER, FDA 2023
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Accelerating Bioprocess Development and Process Analytics Through Digital Innovation
Speaker Presentation Hersch Jana Genedata Tech Seminar 2023
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Implementation of ICH Q12: Reviewers’ Perspective from the Health Canada Pilot Program on ECs and PACMPs
Speaker Presentation Hamel Hugo Health Canada 2023
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Regulatory Perspective on the Applicability of Platform and Prior Knowledge in Product Development
Speaker Presentation Gutierrez Lugo Maria Teresa CDER, FDA 2023
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NIR – Soft Sensor Case Study for Q12 and Q14 Implementation
Speaker Presentation Graul Timothy Pfizer 2023
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Opportunities and Challenges from ICH Q2 (R2) and Q14 for the Analytical Lifecycle
Speaker Presentation Dierick Jean-François GlaxoSmithKline 2023
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FDA’s KASA and PQ/CMC Initiatives:
Perspectives for Biotechnology Products
Speaker Presentation Damdinsuren Bazarragchaa CDER, FDA 2023
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China Clinical Trial Requirements - CMC Specific
Speaker Presentation China Clinical Trial Requirements CMC Specific Mini Case 2023
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Light Scattering Tools for Quantifying Viral Vector Critical Quality Attributes
Speaker Presentation Champagne John Wyatt Tech Seminar 2023
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Best Practices for Lifecycle Management
Speaker Presentation BPOG Collaborations Plenshop 2023
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Cell and Gene Therapy – New Frontier and Our Best Hope to Cure
Speaker Presentation Bauer Steven WFIRM 2023
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Pyramids, Puddings, Fingerprints, and Frogs: Looking Back on 20 years of Platform Development
Speaker Presentation Baker Jeffrey Jeffrey C Baker Consultants 2023