Learning Labs have limited capacity and rooms will fill up quickly! Arrive early to ensure you can secure your spot.
Gain insights from a clinical research expert who will discuss innovative strategies to effectively navigate the complexities of first-in-human (FIH) trials. The session will cover experiences and solutions to overcome common pitfalls and challenges in FIH studies to improve study outcomes. Attendees will enhance their knowledge of FDA, EMA, and MHRA regulatory feedback, adaptive trial design and patient engagement techniques, and real-world success stories to optimize FIH trials and improve study outcomes.
*Global Network Utilization: Learn how the use of a global network of clinical units combined with local expertise addresses specific challenges in FIH studies. *Strategic Approaches: Discover strategies for FIH studies, including adaptive trial designs and patient engagement techniques to overcome common obstacles and improve study outcomes. *Regulatory Insights: Explore the comparison between FDA vs. EMA FIH guidelines and gain insights from regulatory feedback over the past five years from FDA, EMA, and MHRA to navigate regulatory complexities effectively.
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This event is sponsored by an ASCPT Partner organization. The content of the session is provided for informational purposes only and does not constitute or imply ASCPT's endorsement, recommendation, or approval of a specific institution, service, employer, or content.
