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Clinical Trials Guidance Documents Compliance

Canada Consults On Policy Changes For Registering Clinical Trials & Disclosing Results

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Executive Summary

Health Canada is taking steps to improve transparency on authorized clinical trials and is creating a new trials search portal.

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Canada Seeks To Make Decentralized Trials More Practical For Sponsors

By formally adopting a modernized definition of a clinical trial site, Health Canada is hoping to provide greater flexibility to sponsors who want to incorporate decentralized elements in their trials.

European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation

The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.

European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation

The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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