Resources
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Collaborative CMC Assessment of Post-Approval Change Management Protocols: A Regulatory Health Authority-Perspective
Speaker Presentation: WCBP 2026
Wilson Willie, CDER, FDA, 2026 -
Introduction to Session - AI in Development and Manufacturing – New Era in Well Characterized Biologics
Speaker Presentation: WCBP 2026
Thurau Gert, F. Hoffmann-La Roche Ltd., 2026 -
Predictive Stability for
Biopharmaceuticals & Vaccines:
Accelerating Patient Access through Industry
Recommendations and Stakeholder Alignment
Speaker Presentation: WCBP 2026
Skomski Daniel, Merck & Co., Inc., Ji Andrea, Genentech, a Member of the Roche Group, 2026 -
Keynote Speaker - Michael Sheahan, Danforth, Health, Inc.
Speaker Presentation: WCBP 2026
Sheahan Michael, Danforth Health, Inc., 2026 -
Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Droplets in Biopharmaceutical Products
Speaker Presentation: WCBP 2026
Saggu Miguel, Genentech, a Member of the Roche Group, 2026 -
ICH Q1 Guideline Revisions: Risk Frameworks and Regulatory Readiness
Speaker Presentation: WCBP 2026
Russell Paula, Health Canada, 2026 -
Designing the AI-Enabled CMC Ecosystem for Drug Development and Manufacturing
Speaker Presentation: WCBP 2026
Rolandi Pablo, Amgen Inc., 2026 -
SAHPRA Support for Local GMP Manufacturing and Quality Testing
Speaker Presentation: WCBP 2026
Ratlabyana Mphako, South African Health Products Regulatory Authority (SAHPRA), 2026 -
What’s New in the World of Stability Testing?
Updates on ICH Q1/Q5C Revisions
Speaker Presentation: WCBP 2026
Rao Ashutosh, CDER, FDA, 2026 -
ICH M16 - Transitioning to Structured Product Quality Submissions
Speaker Presentation: WCBP 2026
Palacios Rodrigo, F. Hoffmann-La Roche Ltd., 2026 -
Enabling Global Pharmaceutical Innovation
Speaker Presentation: WCBP 2026
Nosal Roger, Vaxcyte, Inc., 2026 -
Enabling the Future of Biopharmaceutical Manufacturing Through Collaborative Innovation
Speaker Presentation: WCBP 2026
Myers Riley, NIIMBL, 2026 -
Overcoming Barriers to local GMP
Manufacturing and testing in LMICs:
Doing Things we never had
Speaker Presentation: WCBP 2026
Makhoana Morena, Biovac, 2026 -
Use of Predictive Stability for Shelf-Life Extension, ICH Q1 Annex 2
Speaker Presentation: WCBP 2026
Lemieux Linda, Merck & Co., Inc., 2026 -
Visible Particle Control in Biologics and Advanced Therapy Products: Challenges, Case Studies, and Evolving Expectations
Speaker Presentation: WCBP 2026
Koulov Atanas, Clear Solutions Laboratories AG, 2026 -
Integrating Artificial Intelligence into Pharmaceutical Manufacturing
Speaker Presentation: WCBP 2026
Kiang Tina, CDER, FDA, 2026 -
Controlling Particulate Matter in Ophthalmic Biologics; Establishing a Risk-Based Analytical Approach to Sub-Visible Particulates
Speaker Presentation: WCBP 2026
Jones Lauren C, Regeneron Pharmaceuticals Inc., 2026 -
Building a Resilient Commercial Supply Chain for Antibody-Drug Conjugate Products: A Risk-Based Comparability Approach
Speaker Presentation: WCBP 2026
Jagani Dipkumar, Astellas Pharma US, Inc., 2026 -
No AI Without
Architecture: FHIR
as the Data
Foundation
Speaker Presentation: WCBP 2026
Hyttel Kåre, NNIT A/S, 2026 -
Machine Learning-Supported (Process) Models: Promises and Practical Implementation Challenges
Speaker Presentation: WCBP 2026
Heinlein Christina, Genentech, a Member of the Roche Group, 2026