Embarking on first-in-human (FIH) trials is a pivotal step in the drug development journey, marking the transition from preclinical research to clinical application. The aim of the session is to demystify the complexities associated with this critical phase.
Join us to gain valuable insights into the strategic planning and execution of Chemistry, Manufacturing, and Controls (CMC) activities, essential for the success of FIH trials. Edouard will explore best practices for managing timelines, ensuring regulatory compliance, and mitigating potential challenges.
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