Resources
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PQS Effectiveness, ICH Q9(R1) & Using the CMC Regulatory Tools of ICH Q12 – a European Regulator’s Perspective
Speaker Presentation: CMC Strategy Forum Japan 2025
O'Donnell Kevin, Health Products Regulatory Authority (HPRA) Ireland, 2025 -
Regulatory Update From European Medicines Agency
Speaker Presentation: CMC Strategy Forum Japan 2025
Mihokovic Nino, European Medicines Agency (EMA), 2025 -
Quality Considerations in the Development of AAV Vector Products
Speaker Presentation: CMC Strategy Forum Japan 2025
Maeda Kenichiro, PMDA, 2025 -
“Tradition Is a Guide Not a Jailer”: Standard Versus Alternative Approaches in the ICH Q1 Revision
Speaker Presentation: CMC Strategy Forum Japan 2025
Lennard Andrew, Amgen Inc., 2025 -
Regulatory Updates and a Perspective on Biologics in Japan
Speaker Presentation: CMC Strategy Forum Japan 2025
Kuribayashi Ryosuke, PMDA, 2025 -
Overview of the ICH-Q1 Guideline Revision Draft and Prospects for Stability Assessment of Biological Products from the Regulatory Perspective
Speaker Presentation: CMC Strategy Forum Japan 2025
Kameda Takashi, PMDA, 2025 -
EMA Quality Innovation Group (QIG): Two Years Experience in Regulatory Support of Innovation in Pharmaceutical Manufacturing
Speaker Presentation: CMC Strategy Forum Japan 2025
Hoefnagel Marcel, Medicines Evaluation Board (MEB), 2025 -
Continuous Manufacturing and Portable On-Demand (POD) for Biologics: Development Challenges and Regulatory Considerations
Speaker Presentation: CMC Strategy Forum Japan 2025
Furuki Kenichiro, Merck Sharp & Dohme, 2025 -
Characterising Viral Vectors for Gene Therapy Delivery Using Mass Spectrometry on Different Levels
Speaker Presentation: CMC Strategy Forum Japan 2025
Bones Jonathan, NIBRT, 2025 -
CMC Strategy Forum Japan 2025 Scientific Program
Scientific Program: CMC Strategy Forum Japan 2025
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CMC Strategy Forum Japan 2025 Summary Infographic
Summary Infographic: CMC Strategy Forum Japan 2025
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In-line Raman Spectroscopy for Process Characterization
Speaker Presentation: Netherlands Area Biotech Discussion Group 2025
Klijn Marieke, Delft University of Technology, 2025 -
Regulatory Expectations for Real-Time PAT and Continuous Manufacturing
Speaker Presentation: Netherlands Area Biotech Discussion Group 2025
Hoefnagel Marcel, Medicines Evaluation Board, 2025 -
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
Speaker Presentation: VEDG 2025
Van Tricht Ewoud, Sanger van de Griend Cari, Kantisto BV, 2025 -
PAT in Biopharmaceutical
Processes
Speaker Presentation: Netherlands Area Biotech Discussion Group 2025
Eppink Michel, Byondis BV, 2025 -
From Vulnerability to Resilience: Industry Strategies for Dealing with Critical Materials in Analytical Procedures
Speaker Presentation: VEDG 2025
Van Tricht Ewoud, Kantisto BV, 2025 -
Few Batches, Big Questions: Navigating AAV Analytical Comparability
Speaker Presentation: CGTP Europe 2025
Schermann Sonya, Ascend LTD, 2025 -
Genetic Engineering of Hematopoietic Cells: From Lentiviral Gene Replacement to Targeted Gene Editing
Speaker Presentation: CGTP Europe 2025
Naldini Luigi, San Raffaele Telethon Institute for Gene Therapy, 2025 -
Single-Cell Sequencing in Cell and Gene Therapy: Opportunities and Challenges for QC and Regulation
Speaker Presentation: CGTP Europe 2025
Muraro Mauro, Single Cell Discoveries BV, 2025 -
EMA Regulatory Update Rapid Fire Session
Speaker Presentation: CGTP Europe 2025
Session 6 Regulatory Panel, 2025