Registration & Coffee 8:30 am - 9:00 am admin
Contamination Control with Efficiency – Integrating Annex 1, Automation and Microbiology 9:00 am - 9:30 am Donald Singer | Chris Berridge, Ecolab Life Sciences
Vaporized hydrogen peroxide (VHP) sterilization and biodecontamination technologies – implications from new regulatory and standards developments (EU Annex 1:2022 and ISO 22441:2022) 9:30 am - 10:00 am Juha Mattila Director, Sterilization Technologies at STERIS Life Sciences admin
Morning Coffee Break 10:00 am - 10:30 am admin
Microbial data investigations and effective implementation roadmap of Contamination Control Strategy 10:30 am - 11:00 am Michele Simone, Corporate Quality Management Director at Bracco
Pattern Recognition and Trending for Regulatory Compliancy and Contamination Control Strategy 11:00 am - 11:30 am Susan Cleary, Director Product Development at Novatek International admin
The Facility Evolution of Small-Scale Cell Therapy 11:30 am - 12:00 pm David Estapé, Senior Process Specialist & Senior Fellow at CRB
Panel Discussion 12:00 pm - 1:00 pm EU GMP Annex 1 Revision ImplementationAseptic Packaging SustainabilityContamination Control Strategies
Lunch & Networking Break 1:00 pm - 2:00 pm
Novel Concept for Isolators to Manufacture ATMP and Biologics 2:00 pm - 2:30 pm Silvia Aldi, Product Manager for Cell & Gene Therapy at SKAN AG
Comparability for genetically modified cells: challenges for vectors and cells 2:30 pm - 3:00 pm Christiane Niederlaender, Vice President Technical CMC at Parexel
Viral vector development and manufacture 3:00 pm - 3:30 pm Magnus Gustafsson Chief Business Officer at Biovian admin
Alternative in vitro models to animal testing : what are the new challenges and opportunities? 3:30 pm - 4:00 pm Edith Filaire, Professor and Scientific Director at ICARE GROUP
Chairperson Closing Remarks and end of the GENAP Summit 4:00 pm - 4:05 pm
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