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Combined Clinical Trials: A Focus on In Vitro Diagnostics
Session Chair(s)
Representative Invited
European Medicines Agency, Netherlands
In this session, we will address the challenges of conducting clinical research in Europe under IVDR and CTR, and explore stakeholder-proposed solutions. We will also discuss the evolving regulatory landscape for combined clinical trials.
Learning Objective : Understand biomarker-driven approvals; Know the role of in vitro diagnostics; Importance of detailed information in applications.
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