Day 2 – Fri, February 24th
Registration & Coffee
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Contamination Control with Efficiency – Integrating Annex 1, Automation and Microbiology
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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)
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Juha Mattila Director, Sterilization Technologies at STERIS Life Sciences
Morning Coffee Break
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Microbial data investigations and effective implementation roadmap of Contamination Control Strategy
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Michele Simone, Corporate Quality Management Director at Bracco
Pattern Recognition and Trending for Regulatory Compliancy and Contamination Control Strategy
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Susan Cleary, Director Product Development at Novatek International
The Facility Evolution of Small-Scale Cell Therapy
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David Estapé, Senior Process Specialist & Senior Fellow at CRB
Panel Discussion
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EU GMP Annex 1 Revision Implementation
Aseptic Packaging Sustainability
Contamination Control Strategies
Novel Concept for Isolators to Manufacture ATMP and Biologics
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Silvia Aldi, Product Manager for Cell & Gene Therapy at SKAN AG
Comparability for genetically modified cells: challenges for vectors and cells
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Christiane Niederlaender, Vice President Technical CMC at Parexel
Viral vector development and manufacture
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Magnus Gustafsson Chief Business Officer at Biovian
Alternative in vitro models to animal testing : what are the new challenges and opportunities?
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Edith Filaire, Professor and Scientific Director at ICARE GROUP
Chairperson Closing Remarks and end of the GENAP Summit
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