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CPHI Milan 2026 Conference Sessions On Demand

Keynote: Europe's Biotech Act II: Setting the Manufacturing Foundation

Day 2 Next-Gen Bio Stage

07/10/2026 11:00 - 11:30am

Contributors

Claire Skentelbery : Director General - EuropaBio

With the EU Biotech Act II launching Q4 2026, Europe stands at a critical juncture where policy ambition must translate into manufacturing reality. This keynote establishes the strategic context: how legislative frameworks, infrastructure investment, and ecosystem coordination are converging to position European bio-manufacturing as a competitive advantage in the global biotechnology landscape.

Key Themes:

  • Legislative Architecture: How Biotech Act II's regulatory streamlining, harmonised approval pathways, and innovation incentives create the policy foundation for manufacturing scale-up across therapeutics, industrial biotech, and circular bioeconomy applications.
  • Infrastructure Readiness: The gap between Europe's scientific excellence and manufacturing execution capability—and what Biotech Act II aims to address through funding mechanisms, facility investment, and workforce development.
  • Strategic Positioning: Why manufacturing readiness is becoming Europe's competitive differentiator against US and Asian markets, and how policy frameworks enable faster commercialisation timelines.