This session will explore best practices, emerging trends, and innovative approaches in regulatory science and the design of clinical trials for new drugs, biologics, and medical devices. Experts from regulatory agencies, industry, and academia will discuss evolving global regulations, ethical considerations, and strategies for navigating complex approval pathways. The session will also cover modern trial designs ? including adaptive trials, decentralized and virtual trials, and real-world data integration ? that help accelerate development timelines while ensuring patient safety and data integrity.