EU regulators have issued much-awaited guidance on the scientific and operational aspects of undertaking complex clinical trials under the EU Clinical Trial Regulation (CTR), which came into force earlier this year, ushering in major changes to how trials are assessed and supervised in the region.
Jointly developed by the European Medicines Agency, the European Commission and the EU Heads of Medicines Agencies, the guideline offers harmonized advice on how companies should plan, set up, seek...
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