Resources
-
Multiple Manufacturing Sites
Speaker Presentation Goering Brad Sanofi 2022
-
Patient-Centric Innovation to Modernize the Development
and Manufacture of Biologics
Speaker Presentation Chen Yan Roche 2022
-
Using Prior Knowledge and Accelerated CMC Tools to Support Early Access to Medicines
Speaker Presentation Barry Sean HPRA CMC Slides 2022
-
EMA Perspectives on ICH M4Q(R2) and Digital Regulatory Assessment
Speaker Presentation Tiitso Klara EMA 2022
-
SubQ Bioavailability Considerations
Speaker Presentation Sanchez-Felix Manuel Novartis 2022
-
Platform Protocol Templates: An Innovative Upcoming Tool for Comparability Assessment and Process Validation
Speaker Presentation Rovira Olga CEPI 2022
-
QIG Overview
Speaker Presentation Popkin Matthew GSK plc 2022
-
M4Q(R2) - An Industry Perspective
Speaker Presentation Pope Miksinski Sarah AstraZeneca 2022
-
Efficiency Toolbox - CMC Lessons Learned from COVID
Speaker Presentation Pellet Mark AstraZeneca 2022
-
Continuous Manufacturing in Biologics Adoption and Regulatory Engagement
Speaker Presentation Nita Ana Silvia MSD 2022
-
CMC Aspects When Switching from Intravenous to Subcutaneous Formulations
Speaker Presentation Mayer Christian AGES MEA 2022
-
FDA Perspective on Opportunities for Modernization of Regulatory Submissions
Speaker Presentation Markovic Ingrid CBER, FDA 2022
-
Using Stability Prior Knowledge From 'Like-molecules' to Determine Shelf-life
Speaker Presentation Lennard Andrew Amgen Ltd 2022
-
A Personal Perspective on the Use of Models in Module 3
Speaker Presentation Lee Nick HPRA-Health Products Regulatory Authority 2022
-
Setting Acceptance Criteria for Release Specification Based on Limited Batch Data
Speaker Presentation Kirke David BioMarin UK Ltd 2022
-
Novel HCP Analysis and Characterisation Tools Provides Freedom of Operation for Efficient Process Development
Speaker Presentation Kåre Kristensen Brian Novo Nordisk 2022
-
How to Leverage Pharmaceutical Development and Manufacturing Data for Marketing Authorisations - EMA's Perspective
Speaker Presentation Jekerle Veronika EMA 2022
-
Modelling of Subcutaneous Injection & Bioavailability to Bridge IV/SubQ
Speaker Presentation Gresham Joel Crux 2022
-
Regulatory Considerations for the Application of Multi-Attribute Methods by Mass Spectrometry for QC Release and Stability Testing of Biopharmaceuticals
Speaker Presentation Gervais Annick UCB_EFPIA 2022
-
A Roadmap to Get Host Cells Proteins Analysis by Mass Spectrometry in a GMP Environment
Speaker Presentation Chéry Cyrille UCB 2022