Clinical Trials & Regulatory Science in Endocrinology

This track provides a deep dive into the evolving landscape of clinical trials and regulatory frameworks guiding the development of endocrine therapies, medical devices, and diagnostics. Presentations will discuss trial design, recruitment approaches, endpoint selection, real-world evidence integration, and adaptive study methodologies tailored for metabolic and hormonal disorders. Experts will cover regulatory expectations for new drug applications, device approvals, biosimilar development, and safety monitoring protocols.

The second part highlights global regulatory harmonization, post-market surveillance, and ethical considerations in trial conduct. Sessions will examine patient-centric trial models, diversity and inclusion in study populations, digital trial platforms, and decentralized monitoring technologies. Case-based discussions will illustrate lessons learned from recent endocrine clinical trials, while industry experts will offer insights into submission strategies and regulatory innovation. This track equips participants with a robust understanding of the processes that bring endocrine breakthroughs from research to market.

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