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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 -
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
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Taking Knowledge Management into the Cloud: Using Structured Data in a Cloud-Based Ecosystem to Enable Reusability, Agility, and Interoperability
Speaker Presentation Algorri Rita Amgen 2023
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Innovative Drug and Device
Technologies and their
impact on Quality Systems,
Control Strategies and Risk
Management (Part I)
Speaker Presentation Akouka Henri Teva Pharmaceuticals USA, Inc. 2023
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Recent Trends in the Regulation of Biological Products in Paraguay
Speaker Presentation Rolon Julio DNVS 2020
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Health Canada: Update on Regulatory
Activities & Priorities
Speaker Presentation Ridgway Anthony Health Canada 2020
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Biologics in Brazil: Overview and Perspectives
Speaker Presentation Rama Elkiane ANVISA 2020
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Adaptable, Flexible, or Novel: Regulatory Frameworks for Advanced Therapies
Speaker Presentation Francissen Kathy Genentech, A Member of the Roche Group 2020
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Robust Bispecific Process Development and Commercial Manufacturing Platform
Speaker Presentation Alfonso Pedro Janssen 2020
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Holistic Control Strategy – from Molecular Design to Combination Product
Speaker Presentation Webb Chandra Pfizer 2020
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Raman Spectroscopy as a Rapid Analytics Tool
Speaker Presentation Springall Jeremy AstraZeneca 2020
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Radically Effective Therapies in Oncology and Infectious Disease
Speaker Presentation Schrader Michael Vaxess 2020