Fireside chat Regulatory Strategy track
Mastering the Shifting Regulatory Landscape: Leveraging the Biotech Act for Innovation and Global Success
Tue, Nov 10, 2026 · 3:00–3:45 PM CET Regulatory Strategy Stage, Koelnmesse
About this session
Understanding the impact of the EU Biotech Act, ATMP, and SoHO Regulations on ATMP development and Biosimilars Building a unified approach to Hospital Exemption to accelerate ATMP access and drive Europe's innovation and competitive edge forward Comparing the EU regulatory framework with the MHRA Rare Therapies Launch Pad and its support for innovation Exploring the FDA’s framework for accelerating individualized therapies and its implications for global competitiveness Identifying key strategies for biotech manufacturers to adapt to evolving regulatory requirements and seize new opportunities
