Clinical Trials & Regulatory Affairs

This session focuses on the evolving landscape of clinical trial design and the global regulatory frameworks that govern them. As trials become more patient-centric and data-driven, professionals must stay ahead of regulatory shifts and ethical standards. The session will include a thorough overview of traditional versus decentralized trials. Special emphasis will be placed on adaptive trial designs, platform trials, and real-world evidence integration. Experts will share examples of how digital technologies, wearable devices, and AI tools have optimized trial conduct and compliance.

The session will also analyze the increasingly complex global regulatory environment. Presenters from regulatory bodies and industry will explore strategies for navigating multi-country approvals, IND/CTA submissions, and post-marketing surveillance. Interactive panels will discuss strategies for improving patient recruitment and retention, including diversity initiatives. The patient voice in trial design will also be a critical focal point, promoting engagement and ethics. Attendees will gain practical tools for ensuring trial efficiency and compliance, bridging innovation with regulatory expectations to improve timelines and patient outcomes.

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