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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 : Explain the key principles involved in biomarker-driven approvals; Describe the role of in vitro diagnostics; Identify the types of detailed information required in applications to meet regulatory expectations for biomarker-guided medicinal products.
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