Fireside chat Clinical Strategy track
Navigating the Evolving Regulatory Landscape: Strategies for Clinical Success in an Era of Transformation
Tue, Nov 10, 2026 · 2:00–2:25 PM CET Clinical Strategy Stage, Koelnmesse
About this session
Address unique regulatory hurdles and innovative approval pathways for rare disease clinical trials, including adaptive designs and strategies for generating robust evidence with limited patient populations Examine the impact of political and leadership changes at the FDA and across global regulatory agencies, and how these shifts influence drug development priorities, review timelines, and enforcement approaches Align trial design with evolving regulatory requirements by incorporating real-world evidence, digital endpoints, and quality-by-design principles that strengthen submissions and…
