
Resources
Home
/
Resources
-
WCBP 2023 Waters Technical Seminar
Speaker Presentation Technical Seminar Presented by Waters Corporation 2023 -
Complex Characterization Challenges and Analytical Solutions for Development of AAV Products
Speaker Presentation Technical Seminar Presented by Protagene 2023 -
Drug Delivery Devices A Market Perspective and Technology Discussion
Speaker Presentation Romacker Mathias Kymanox 2023 -
Risk Versus Benefit: Acceleration of CMC for Biologics/Vaccines Products
Speaker Presentation Risk Versus Benefit Acceleration of CMC for Biologics Vaccines Products Mini Case 2023 -
Platform Analytical Method Lifecycle: Trends, Strategies, and Case Study Through the Lens of mRNA Vaccines
Speaker Presentation Ripley David Pfizer, Inc. 2023 -
Q12 Topics and Applicability to Global Markets: Challenges for Global Expansion
Speaker Presentation Q12 Topics and Applicability to Global Markets Challenges for Global Expansion Mini Case 2023 -
Mass Photometry - An Innovative Biophysical Analysis Tool with Numerous Applications
Speaker Presentation Pre-Record Vendor Showcase Presented by Refeyn 2023 -
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 -
Update on ICH M4Q(R2) and Industry perspective
Speaker Presentation Nielsen Henrik Kim Novo Nordisk 2023 -
Win, Lose or Draw - The ICH Q12 Experience from the Industry Perspective
Speaker Presentation Luu Minh Genentech, a Member of the Roche Group 2023 -
Harnessing the Invaluable Tribal Knowledge Hidden in Your Organization
Speaker Presentation Lipa Martin Merck and Co., Inc. 2023 -
Regulatory Considerations for Keeping Things Moving
Speaker Presentation Levis Robin CBER, FDA 2023 -
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 -
Implementation of ICH Q12: Successes and Challenges
Speaker Presentation Implementation of ICH Q12 Successes and Challenges Workshop 2023 -
FDA/CDER Perspectives on Analytical Procedure Development and Validation
Speaker Presentation Hsu Amy CDER, FDA 2023 -
Accelerating Bioprocess Development and Process Analytics Through Digital Innovation
Speaker Presentation Hersch Jana Genedata Tech Seminar 2023 -
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 -
NIR – Soft Sensor Case Study for Q12 and Q14 Implementation
Speaker Presentation Graul Timothy Pfizer 2023